A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

University of Chicago8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Anesthesia

Interventions

Eligibility

Sex: MALEMin age: 25 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.

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.

Time frame: 15 minutes

Secondary Outcomes

Cognitive Test1 - Visual Analog Scale

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.