A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

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The University of Chicago

Status and phase

Completed
Phase 4

Conditions

Anesthesia

Treatments

Drug: Placebo
Drug: Caffeine

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03360903
1R01GM116119 (U.S. NIH Grant/Contract)
IRB17-1174

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

25 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 25-40.
  • Male.
  • Normal healthy subject without systematic diseases or conditions.
  • Metabolic Equivalents of Functional Capacity >= 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
  • No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
  • BMI < 30 kg/m2.
  • No history of prior difficulty with anesthesia.
  • No personal or family history of malignant hyperthermia.
  • No history of any mental illness.
  • No history of drugs or alcohol abuse (urine drug screens required).
  • Subjects capable of giving consent.
  • Living less than 30 miles away from University of Chicago.
  • No history of seizure disorders.
  • No history of head trauma.

Exclusion criteria

  • Age <25 or >40.
  • Female.
  • ASA physical status > 1 (normal healthy subject without systematic diseases or conditions)
  • Metabolic Equivalents of Functional Capacity (METs) < 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
  • History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
  • BMI>30 kg/m2.
  • Prior difficulty with anesthesia.
  • Personal or family history of malignant hyperthermia.
  • History of any mental illness.
  • History of drugs or alcohol abuse (urine drug screens required)
  • Subjects not capable of giving consent
  • Living more than 30 miles away from University of Chicago.
  • History of seizure disorders.
  • History of head trauma.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

8 participants in 2 patient groups

Placebo then Caffeine
Experimental group
Description:
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).
Treatment:
Drug: Caffeine
Drug: Placebo
Caffeine then Placebo
Experimental group
Description:
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).
Treatment:
Drug: Caffeine
Drug: Placebo

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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