Clinical trial NCT02567968: A Study to Determine if Caffeine Accelerates Emergence From Anesthesia
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2015-10-05
Enrollment: 8
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 and mice to wake much more rapidly from 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 investigators carried out a modest trial with 8 test subjects. Each volunteer was anesthetized twice. Each volunteer was anesthetized one time and received an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer received an infusion of a relatively low dose of caffeine. The order of saline versus caffeine was randomized and the study was done in a double blind manner. We observed that emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse events were 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 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.

Primary outcomes:
measure: Waking Time - Re-establishment of the Gag Reflex.
timeFrame: followed from the end of anesthesia to gag reflex, up to 2 hours
Secondary outcomes:
measure: Cognitive Test1 - Visual Analog Scale --- Feel Good
timeFrame: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
measure: Cognitive Test1 - Visual Analog Scale --- Feel Bad
timeFrame: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
measure: Cognitive Test2 - Sternberg Test of Memory
timeFrame: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
measure: Cognitive Test3 - Divided Attention Task
timeFrame: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
measure: Bispectral Index
timeFrame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
measure: Minute Ventilation
timeFrame: Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.
measure: Mean Arterial Blood Pressure
timeFrame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
measure: Heart Rate
timeFrame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Aaron Fox, PhD
role: PRINCIPAL_INVESTIGATOR
References: