Apparatus and method for providing a conscious patient relief from pain and anxiety associated with medical or surgical procedures

• US 6,807,965 B1
• Filed: 06/03/1999
• Issued: 10/26/2004
• Est. Priority Date: 06/03/1998
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): PATEL, MITAL B
• Application Number:
  US09/324,759
• Time in Patent Office: 1,972 Days
• Field of Search: 600/300, 600/301, 604/65, 604/66, 604/67, 128/204.23, 128/206.25, 128/DIG.13
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/162 Testing reaction times
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0078 Breathing bags
• CPC Class Codes: A61M 16/0084 self-reinflatable by elasticity, e.g. resuscitation squeeze bags
• CPC Class Codes: A61M 16/009 Removing used or expired gases or anaesthetic vapours filtering, sterilising or disinfecting the exhaust air in drainage systems A61M1/784; bacterial filters in the expiratory path A61M16/1065
• CPC Class Codes: A61M 16/0093 by adsorption, absorption or filtration
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/1015 using a gas flush valve, e.g. oxygen flush valve
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/43 : Composition of exhalation
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y10T 428/24355 : Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]

Abstract

A care system and associated methods are provided for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures. Embodiments of the system include a health monitor device coupled to a patient and generating a signal reflecting at least one physiological condition of the patient; a drug delivery controller supplying one or more drugs to the patient; a memory device storing a safety data set reflecting parameters of at least one patient physiological condition; and an electronic controller interconnected between the patient health monitor, the drug delivery controller and the safety data set. The electronic controller is capable of effecting a change in the drug supply delivered to the patient by the drug controller, said change depending on a comparison between at least one patient physiological condition at its corresponding value reflected in the safety data set.

Claims

1. A care system for facilitating safely and efficaciously providing sedation to a patient undergoing a medical or surgical procedure, said system comprising:

a patient health monitor device adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient;

a drug delivery controller supplying one or more drugs to a patient;

a means for monitoring the consciousness of the patient adapted so as to be coupled to the patient and generate a value representing a level of patient consciousness;

a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition and of patient consciousness level; and

an electronic controller interconnected between the patient health monitor, the drug delivery controller, and the memory device storing the safety data set;

wherein said electronic controller manages application of the drugs to the patient in response to said signal and said level in accord with the safety data set.

2. The care system according to claim 1, wherein said safety data set defines a preset normal range of said at least one physiological condition and said level, and wherein said electronic controller conservatively manages delivery of drugs by said drug delivery controller if at least one of said condition or said level is determined by said controller to be outside of said preset normal range.

3. The care system according to claim 2, wherein said preset normal range is identified by at least one threshold for said signal or said level.

4. The care system according to claim 3, wherein said safety data set defines at least two thresholds concerning at least one of said physiological condition or said level, wherein said thresholds designate different levels of concern for said patient outside of said preset normal range.

5. The care system according to claim 4, further comprising an operator interface, and wherein said electronic controller causes an alarm to be raised by said interface if said physiological condition or said level crosses a first of said thresholds, and wherein said controller causes said drug delivery controller to decrease drug delivery if said physiological condition or said level crosses a second of said second threshold.

6. The care system according to claim 1, wherein said means for monitoring the consciousness of the patient comprises a stimulator device and a response device, said stimulator device adapted to command a patient with a prompt and said response device adapted to be activated by the patient in response to the prompt, and wherein said response device generates said value reflecting the time it takes for the patient to activate the response device in response to the prompt.

7. The care system according to claim 6, wherein said stimulator device comprises a sound delivery device that provides an auditory prompt to a patient.

8. The care system according to claim 6, wherein said stimulator device comprises a vibrator that provides a tactile prompt to a patient.

9. The care system according to claim 1, wherein said electronic controller and said means for monitoring the consciousness of the patient are adapted to perform an automated assessment of a physiological state of the patient.

10. The care system according to claim 9, wherein said automated assessment is performed prior to beginning drug delivery.

11. The care system according to claim 10, wherein said automated assessment determines a sedation threshold limit for the patient in an unstimulated state.

12. The care system according to claim 11, wherein said sedation threshold limit is used to determine an initial drug delivery level.

13. The care system according to claim 9, wherein said electronic controller receives said signal from said patient health monitor during said assessment.

14. The care system according to claim 1, wherein said one or more drugs comprise propofol.

15. The care system according to claim 1, wherein said one or more drugs comprise remifentanil.

16. The care system according to claim 1, wherein said drug delivery controller is a controllable drug delivery mechanism selected from the group consisting of a continuous infusion pump, a target controlled infusion pump, a bolus infusion device, and combinations thereof.

17. An apparatus for delivering drugs to a patient, said apparatus comprising:

a drug delivery controller delivering a drug to a patient;

an electronic controller connected to the drug delivery controller for varying the rate of delivery of drug to a patient;

an automated consciousness monitoring system which generates a signal reflecting the consciousness level of a patient; and

wherein said electronic controller is capable of varying the delivery of drug to the patient in accord with said signal.

18. The apparatus as recited in claim 17 wherein said automated consciousness monitoring system comprises a stimulator device which commands a patient;

and a response device for activation by the patient in response to the stimulator device;

said response device generating signals having values reflecting the time it takes for the patient to activate the response device in response to the stimulator device, and providing said signals to the electronic controller.

19. The apparatus as recited in claim 18 wherein said stimulator device has multiple urgency or intensity levels.

20. The apparatus as recited in claim 18, in which the stimulator device comprises a speaker that provides an auditory instruction to a patient.

21. The apparatus as recited in claim 18 in which the stimulator device comprises a vibrator.

22. The apparatus as recited in claim 18 wherein the stimulator device is located in close proximity to the response device.

23. The apparatus as recited in claim 17, wherein said apparatus also includes at least one patient health monitor device which generates a signal reflecting at least one physiological condition of a patient.

24. The apparatus as recited in claim 17 wherein said drug delivery controller includes a patient-controlled drug administration device.

25. The apparatus as recited in claim 17 wherein said apparatus also includes a display device displaying the value of the signal reflecting the consciousness level of the patient.

26. The apparatus as recited in claim 17, wherein said apparatus further includes an attention-commanding device which receives said signal reflecting the consciousness level of the patient and notifies an operator in the event said consciousness level changes to a level outside an acceptable range.

27. The apparatus as recited in claim 26 wherein said attention-commanding device is an audible alarm.

28. The apparatus as recited in claim 26, wherein said apparatus further includes a display device which displays the value reflecting the consciousness level of the patient upon activation of said attention-commanding device and visually displays an action to be taken by said electronic controller in the event said consciousness level is outside of an acceptable range.

29. The apparatus according to claim 17, wherein said automated consciousness monitoring system measures the responsiveness of a patient to stimuli to generate said signal reflecting the consciousness level of a patient.

30. The apparatus as recited in claim 17, wherein said electronic controller and said consciousness monitoring system are adapted to perform an automated assessment of a physiological state of the patient.

31. The apparatus as recited in claim 30, wherein said automated assessment is performed prior to beginning drug delivery.

32. The apparatus as recited in claim 30, wherein said automated assessment determines a sedation threshold limit for the patient in an unstimulated state.

33. The apparatus as recited in claim 32, wherein said sedation threshold limit is used to determine an initial drug delivery level.

34. The apparatus as recited in claim 17, wherein said drug delivery controller is a controllable drug delivery mechanism selected from the group consisting of a continuous infusion pump, a target controlled infusion pump, a bolus infusion device, and combinations thereof.

35. A method for relieving patient pain or anxiety, said method comprising the steps of:

a) monitoring at least one physiological condition of a patient with at least one electronic health monitor device;

b) electronically monitoring the level of consciousness of a patient; and

c) electronically managing the delivery of pain or anxiety relieving drugs to a patient in accord with the at least one physiological condition of a patient and the level of consciousness of a patient.

36. The method as recited in claim 35 in which the electronic health monitor device is a pulse oximeter and the delivery of drugs is electronically managed in accord with the level of oxygen in the patient'"'"'s blood.

37. The method as recited in claim 35 in which the monitoring of the level of consciousness of a patient further comprises the steps of:

a) automatedly commanding the attention of the patient with a stimulus;

b) electronically receiving the patient'"'"'s response to the stimulus;

c) generating a signal having a value reflecting the level of consciousness of a patient as a function of the time it took for the patient to respond to the stimulus.

38. The method as recited in claim 35 in which the delivery of drugs is accomplished through a mechanism selected from the group consisting of continuous infusion, target controlled intravenous infusion, bolus infusion, and combinations thereof.

39. The method as recited in claim 35 in which the delivery of drugs is partially accomplished by a patient-controlled drug delivery device.

40. The method as recited in claim 35, wherein the drugs are delivered in gaseous form.

41. The method as recited in claim 35, wherein said drugs comprise propofol.

42. The method as recited in claim 35, wherein said drugs comprise a sedative.

43. The method as recited in claim 35, wherein said pain or anxiety is associated with an ongoing surgical or medical procedure.

44. The method as recited in claim 35, wherein said managing of said delivery of drugs comprises conservatively managing drug delivery when said physiological condition is outside safe parameters.

45. The method according to claim 44, further comprising defining at least two thresholds concerning said physiological condition, wherein said thresholds designate different levels of concern or criticality outside of said preset normal range.

46. The method according to claim 45, further comprising sounding an alarm if said physiological condition crosses said first threshold, and decreasing drug delivery if said physiological condition crosses said second threshold.

47. The method as recited in claim 35, wherein said managing of said delivery of drugs comprises conservatively managing drug delivery when said physiological condition and said level of consciousness collectively demonstrate said patient is outside of a preset normal range.

48. The method as recited in claim 35, wherein said managing of said delivery of drugs comprises conservatively managing drug delivery when said level of consciousness is outside of safe parameters.

49. A method for alleviating pain and anxiety in connection with medical and surgical procedures, said method comprising the steps of:

a) connecting to a patient a drug delivery device having a drug delivery controller supplying one or more drugs, said drug delivery controller being coupled to an electronic controller which controls the delivery of the drugs to the patient;

b) attaching at least one patient health monitor device to a patient, which health monitor device generates a value reflecting at least one physiological condition of a patient and is coupled to said electronic controller;

c) accessing a memory device which stores a safety data set reflecting parameters of at least one patient physiological condition;

d) performing an automated assessment of the patient'"'"'s physiological state; and

e) delivering the drugs to the patient in accord with the safety data set.

50. The method as recited in claim 49, wherein the automated assessment is performed pre-operatively.

51. The method as recited in claim 50 in which the pre-op assessment includes determining a patient sedation threshold limit.

52. The method as recited in claim 49 in which the electronic controller manages drug delivery in accord with the automated assessment.

53. The method as recited in claim 49 in which the drug is propofol.

54. The method as recited in claim 49 in which the drug is a sedative.

55. The method as recited in claim 49 in which the delivering of the drugs step is accomplished by a mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

56. The method as recited in claim 55 in which the drug is initially delivered in an amount overshooting a steady state target drug level.

57. The method as recited in claim 49 in which the patient health monitor device is a pulse oximeter and the application of drug is managed in accord with the oxygen level of the patient'"'"'s blood.

58. The method as recited in claim 49 in which said patient health monitor is a patient consciousness monitor that operably monitors responses of patients to stimuli.

59. The method according to claim 49, wherein said safety data set defines a preset normal range of said at least one physiological condition.

60. The method according to claim 59, wherein said delivering of drugs in accord with said safety data set comprises conservatively managing drug delivery when said generated value of said physiological condition indicates an unsafe patient condition relative to said safety data set strays outside of said preset normal range.

61. The method according to claim 59, wherein said safety data set defines at least two thresholds concerning said physiological condition, wherein said thresholds designate different levels of concern outside of safe parameters.

62. The method according to claim 61, further comprising raising an alarm if said physiological condition value crosses a first of said thresholds, and decreasing drug delivery if said physiological condition value crosses a second of said thresholds.

63. The method according to claim 59, wherein said preset normal range is identified by at least one threshold pertaining to said value.

64. The method according to claim 49, wherein delivery of said drugs is performed by a mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

65. An apparatus for delivering drugs to a patient, said apparatus comprising:

a drug delivery controller delivering a drug to a patient;

an electronic controller connected to the drug delivery controller for varying the rate of delivery of drug to a patient;

an automated consciousness monitoring system which generates a signal reflecting the consciousness level of a patient, said automated consciousness monitoring system comprising a stimulator device which commands a patient and a response device for activation by the patient in response to the stimulator device;

said response device generating signals having values reflecting the time it takes for the patient to activate the response device in response to the stimulator device, and providing said signals to the electronic controller; and

wherein said electronic controller is capable of varying the delivery of drug to the patient in accord with said signal.

66. The apparatus as recited in claim 65 wherein said stimulator device has multiple urgency or intensity levels.

67. The apparatus as recited in claim 65 in which the stimulator device comprises an auditory device that provides an auditory instruction to a patient.

68. The apparatus as recited in claim 65 in which the stimulator device comprises a vibrator.

69. The apparatus as recited in claim 65, wherein the stimulator device is located in close proximity to the response device.

70. The apparatus as recited in claim 65, wherein said apparatus also includes at least one patient health monitor device which generates a signal reflecting at least one physiological condition of a patient.

71. The apparatus as recited in claim 65, wherein said drug delivery controller includes a patient-controlled drug administration device.

72. The apparatus as recited in claim 65, wherein said apparatus also includes a display device displaying the value of the signal reflecting the consciousness level of the patient.

73. The apparatus as recited in claim 65, wherein said electronic controller and said consciousness monitoring system are adapted to perform an automated assessment of a physiological state of the patient.

74. The apparatus as recited in claim 73, wherein said automated assessment is performed prior to beginning drug delivery.

75. The apparatus as recited in claim 73, wherein said automated assessment determines a sedation threshold limit for the patient in an unstimulated state.

76. The apparatus as recited in claim 75, wherein said sedation threshold limit is used to determine an initial drug delivery level.

77. The apparatus as recited in claim 65, wherein said electronic controller varies said delivery of said drugs by conservatively managing drug delivery when said values reflect levels of responsiveness outside of preset safe parameters.

78. The apparatus as recited in claim 77, further comprising a memory accessible by said electronic controller, said memory storing information regarding said pre-set normal range.

79. The apparatus as recited in claim 77, wherein said preset normal range is identified by at least one threshold pertaining to said values in said signals.

80. The apparatus as recited in claim 77, wherein said levels of responsiveness outside of said preset normal range are identified by multiple thresholds that designate different levels of concern for said patient.

81. The apparatus as recited in claim 80, further comprising means for communicating an alarm condition, and wherein said electronic controller is adapted to raise an alarm via said means for communicating if said values cross a first threshold, and wherein said electronic controller is adapted to instruct said drug delivery controller to decrease drug delivery if said values cross a second threshold.

82. The apparatus as recited in claim 65, wherein said drug comprises propofol.

83. The apparatus as recited in claim 65, wherein said drug comprises remifentanil.

84. The apparatus as recited in claim 65, wherein said drug delivery controller is a controllable drug delivery mechanism selected from the group consisting of a continuous infusion pump, a target controlled infusion pump, a bolus infusion device, and combinations thereof.

85. An apparatus for delivering drugs to a patient, said apparatus comprising:

a drug delivery controller for delivering a drug to a patient;

an electronic controller connected to the drug delivery controller for varying the rate of delivery of drug to the patient;

an automated monitoring system which queries the responsiveness of the patient to stimuli and thereby generates a signal reflecting the consciousness level of the patient; and

wherein said electronic controller is adapted to use said signal to vary delivery of drug to the patient in accord with said consciousness level.

86. The apparatus according to claim 85, wherein said automated monitoring system comprises a stimulator device which commands the patient with a prompt;

and a response device for activation by the patient in response to the prompt;

said response device generating signals having values reflecting the time it takes for the patient to activate the response device in response to the prompt and then providing said signals to the electronic controller.

87. The apparatus according to claim 86, wherein the stimulator device comprises an auditory device that provides an auditory prompt to a patient.

88. The apparatus according to claim 85, wherein said apparatus also includes at least one patient health monitor device which generates a second signal reflecting at least one physiological condition of a patient.

89. The apparatus according to claim 88, further comprising a memory accessible by said electronic controller, said memory storing information regarding preset normal ranges of said responsiveness levels and said physiological condition signals, wherein said electronic controller conservatively manages delivery of drugs by said drug delivery controller if at least one of said responsiveness levels or said physiological condition signals is determined by said controller to be outside of said preset normal range.

90. The apparatus according to claim 85, wherein the delivery of the drug is varied by said electronic controller to ensure the consciousness of the patient.

91. The apparatus according to claim 85, wherein said electronic controller and said automated monitoring system are adapted to perform an automated assessment of a physiological state of the patient.

92. The apparatus according to claim 91, wherein said automated assessment is performed prior to beginning drug delivery.

93. The apparatus according to claim 91, wherein said automated assessment determines a sedation threshold limit for the patient in an unstimulated state.

94. The apparatus according to claim 93, wherein said sedation threshold limit is used to determine an initial drug delivery level.

95. The apparatus according to claim 85, wherein said electronic controller varies said delivery of said drugs by conservatively managing drug delivery when a current responsiveness level signaled by said automated monitoring system is determined to reflect unsafe levels of responsiveness.

96. The apparatus according to claim 95, further comprising a memory accessible by said electronic controller, said memory storing information regarding a preset range of safe responsiveness levels.

97. The apparatus according to claim 96, wherein said preset normal range is identified by at least one threshold pertaining to said responsiveness levels.

98. The apparatus according to claim 96, wherein said levels of responsiveness outside of said preset normal range are identified by multiple thresholds that designate different stages of concern or criticality for said patient.

99. The apparatus according to claim 98 further comprising means for communicating an alarm condition, and wherein said electronic controller is adapted to raise an alarm via said means for communicating if said levels cross a first threshold, and wherein said electronic controller is adapted to instruct said drug delivery controller to decrease drug delivery if said levels cross a second threshold.

100. The apparatus according to claim 85, wherein said drug delivery controller is a controllable drug delivery mechanism selected from the group consisting of a continuous infusion pump, a target controlled infusion pump, a bolus infusion device, and combinations thereof.

101. The apparatus according to claim 85, wherein said drug comprises propofol.

102. The apparatus according to claim 85, wherein said drug comprises a sedative.

103. An apparatus for delivering drugs to a conscious patient, said apparatus comprising:

a drug delivery control device adapted to deliver a drug to a patient;

an electronic controller connected to the drug delivery control device for varying the rate of delivery of drug to the patient;

an automated consciousness monitoring system which generates a signal reflecting the consciousness level of the patient; and

wherein said electronic controller is adapted to receive said signal and vary delivery of the drug to the patient in accord with said signal so as to ensure the consciousness of the patient.

104. The apparatus according to claim 103, wherein said electronic controller is adapted to vary delivery of the drug to the patient in accord with said signal so as to reduce drug delivery as the patient demonstrates diminished ability to respond to a stimulus.

105. The apparatus according to claim 103, wherein said apparatus also includes at least one patient health monitor device which generates a second signal reflecting at least one physiological condition of a patient, and wherein said electronic controller is adapted to vary delivery of the drug to the patient in accord with said second signal to maintain said physiological condition within predetermined safe parameters.

106. The apparatus according to claim 103, wherein the delivery of the drug is varied by said electronic controller to maintain an adequate consciousness level of the patient.

107. The apparatus according to claim 103, wherein said drug delivery control device is an electronically controllable drug delivery mechanism selected from the group consisting of a continuous infusion pump, a target controlled infusion pump, a bolus infusion device, and combinations thereof.

108. The apparatus according to claim 103, wherein said electronic controller and said automated consciousness monitoring system are adapted to perform an automated assessment of a physiological state of the patient.

109. The apparatus according to claim 108, wherein said automated assessment is performed prior to beginning drug delivery.

110. The apparatus according to claim 108, wherein said automated assessment determines a sedation threshold limit for the patient in an unstimulated state.

111. The apparatus according to claim 110, wherein said sedation threshold limit is used to determine an initial drug delivery rate.

112. The apparatus according to claim 103, wherein said electronic controller varies said delivery of said drugs by conservatively managing drug delivery when said levels reflect levels of consciousness outside of a desired normal range.

113. The apparatus according to claim 112, further comprising a memory accessible by said electronic controller, said memory storing information regarding said normal range.

114. The apparatus according to claim 112, wherein said normal range is identified by at least one threshold pertaining to information in said signal from said monitoring system.

115. The apparatus according to claim 112, wherein said levels of consciousness outside said preset normal range are identified by multiple thresholds that designate different levels of concern for said patient.

116. The apparatus according to claim 115, further comprising means for communicating an alarm condition, and wherein said electronic controller is adapted to raise an alarm via said means for communicating if a detected consciousness level crosses a first threshold, and wherein said electronic controller is adapted to instruct said drug delivery controller to decrease drug delivery if said detected consciousness level crosses a second threshold.

117. The apparatus according to claim 103, further comprising at least one patient health monitor connected to said electronic controller, said patient health monitor being adapted to be connected to the patient and to generate a second signal reflecting at least one physiological condition of the patient, and wherein said signal from said automated consciousness monitoring system and said second signal are monitored by said electronic controller, said electronic controller using said signals to cause said drug delivery control device to decrease drug delivery if said signals indicate the patient is exhibiting predetermined unsafe parameters.

118. A method for relieving patient pain or anxiety, said method comprising the steps of:

establishing safe and undesirable parameters regarding the consciousness level of a patient being administered pain or anxiety relieving drugs;

electronically monitoring the level of consciousness of the patient; and

electronically managing the delivery of said pain or anxiety relieving drugs to the patient in accord with a comparison of the monitored level of consciousness of the patient and said parameters.

119. The method according to claim 118, wherein said managing of drug delivery comprises a reduction of drug administration rate whenever the monitored level of consciousness is undesirable.

120. The method according to claim 118, wherein said monitoring step further comprises commanding the patient with a prompt, monitoring the patient for a response to the prompt, and generating a signal having a value reflecting a period of time it takes for the patient to respond to said prompt.

121. The method according to claim 118, further comprising performing an automated assessment of the patient'"'"'s physiological state.

122. The method according to claim 121, wherein the automated assessment is performed pre-operatively.

123. The method according to claim 122, in which the pre-op assessment includes determining a patient sedation threshold limit.

124. The method according to claim 123, wherein said sedation threshold limit is used to determine an initial drug delivery rate.

125. The method according to claim 118, wherein said managing of said delivery of drugs comprises conservatively managing drug delivery when said level of consciousness is outside of a preset normal range.

126. The method according to claim 125, wherein managing the delivery of said drugs comprises conservatively managing when said monitored level of consciousness strays outside of said preset safe parameters.

127. The method according to claim 126, wherein parameters outside of said preset normal range are categorized by at least two thresholds, wherein said thresholds designate different levels of concern or criticality outside of said preset normal range.

128. The method according to claim 118, wherein said drugs comprise propofol.

129. The method according to claim 118, wherein said drugs comprise a sedative.

130. The method according to claim 118, wherein said electronic drug delivery is performed utilizing a drug delivery mechanism selected from the group consisting of a continuous infusion pump, a target controlled infusion pump, a bolus infusion device, and combinations thereof.