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A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

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ClinicalTrials.gov Identifier: NCT03360903
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats to wake much more rapidly from propofol anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?

The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer will be anesthetized twice. Each volunteer will be anesthetized one time and receive an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer will receive an infusion of a relatively low dose of caffeine. The order of saline versus caffeine will be randomized and the study will be done in a double blind manner. We will determine whether emergence from propofol anesthesia will be significantly accelerated by the caffeine infusion. And whether any adverse events are observed.


Condition or disease Intervention/treatment Phase
Anesthesia Drug: Placebo Drug: Caffeine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia
Estimated Study Start Date : January 2, 2018
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Placebo Comparator: Placebo
Anesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured.
Drug: Placebo

Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured.

Other Names:

  • Saline

Active Comparator: Caffeine
Anesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured.
Drug: Caffeine

Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured.

Other Names:

  • Caffeine citrate




Primary Outcome Measures :
  1. Waking Time - Time Between terminating Anesthesia and Subject Opening Eyes. [ Time Frame: 15 minutes ]
    The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.


Secondary Outcome Measures :
  1. Cognitive Test1 - Visual Analog Scale [ Time Frame: Up to 120 minutes after terminating anesthesia. ]
    Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject will be asked to complete a series of psychomotor tests, if they are able. Otherwise the testing started at 30 minutes. The tests will be repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of "feel good" or "feel bad" displayed on a computer screen. Test subjects will be asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test will be repeated every 15 minutes.

  2. Cognitive Test2 - Sternberg Test of Memory [ Time Frame: Up to 120 minutes after terminating anesthesia. ]
    Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test will be applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants are asked to memorize a string of numbers. Afterwards, a computer will flash a series of random numbers on the screen and the participant is asked whether the number on the computer screen are part of the earlier string or not. In three rounds, participants are given a string of 2, then 4, then 6 numbers. The latency until the subject answers the question is also monitored.

  3. Cognitive Test3 - Divided Attention Task [ Time Frame: Up to 120 minutes after terminating anesthesia. ]
    Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test is first applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants are asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flash on the screen. The computer program tracks the root mean squared (RMS) deviation of the plane from the center of the road and the latency for pressing the trigger when the target appears.

  4. Bispectral Index [ Time Frame: Up to 120 minutes after terminating anesthesia. ]
    A bispectral index (BIS) measurement system is employed to measure depth of anesthesia. In particular, we wish to determine whether BIS exhibits more rapid recovery after caffeine compared to control.

  5. Mean Arterial Blood Pressure [ Time Frame: Up to 120 minutes after terminating anesthesia. ]
    This measurement is made in order to determine whether caffeine alters blood pressure in a deleterious manner.

  6. Heart rate [ Time Frame: Up to 120 minutes after terminating anesthesia. ]
    This measurement is made in order to determine whether caffeine alters heart rate in a deleterious manner.



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 25-40.
  2. Male.
  3. Normal healthy subject without systematic diseases or conditions.
  4. Metabolic Equivalents of Functional Capacity >= 5.
  5. Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
  6. No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
  7. BMI < 30 kg/m2.
  8. No history of prior difficulty with anesthesia.
  9. No personal or family history of malignant hyperthermia.
  10. No history of any mental illness.
  11. No history of drugs or alcohol abuse (urine drug screens required).
  12. Subjects capable of giving consent.
  13. Living less than 30 miles away from University of Chicago.
  14. No history of seizure disorders.
  15. No history of head trauma.

Exclusion Criteria:

  1. Age <25 or >40.
  2. Female.
  3. ASA physical status > 1 (normal healthy subject without systematic diseases or conditions)
  4. Metabolic Equivalents of Functional Capacity (METs) < 5.
  5. High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
  6. History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
  7. BMI>30 kg/m2.
  8. Prior difficulty with anesthesia.
  9. Personal or family history of malignant hyperthermia.
  10. History of any mental illness.
  11. History of drugs or alcohol abuse (urine drug screens required)
  12. Subjects not capable of giving consent
  13. Living more than 30 miles away from University of Chicago.
  14. History of seizure disorders.
  15. History of head trauma.

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03360903     History of Changes
Other Study ID Numbers: IRB17-1174
1R01GM116119 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Caffeine
Caffeine citrate
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents