A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
Condition: Anesthesia
Intervention: Placebo; Caffeine
Intervention description: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
Saline; Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
Caffeine citrate
Intervention MeSH terms: Caffeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: Male
Minimum age: 25 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.