A Study to Determine if Caffeine Accelerates Emergence From Anesthesia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

NCT03360903

Anesthesia

COMPLETED PHASE4

Ketamine and Kidney Injury in Cardiac Surgery

NCT05268562

Cardiac Surgery

ACTIVE_NOT_RECRUITING PHASE4

Brain Networks and Consciousness

NCT04502550

Loss of Consciousness Parkinson Disease Essential Tremor +1 more

COMPLETED

Anesthesia sTrategy foR Organ Procurement In braiN dEath

NCT07166991

Brain-dead Organ Donors

NOT_YET_RECRUITING PHASE3

Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis

NCT05256264

Electroencephalographic Density Spectrum Array Analysis Density Spectrum Array Ketamine +1 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caffeine

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

Intervention Type DRUG

Placebo Control

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Caffeine citrate Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes