A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

NCT ID: NCT03360903

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2019-06-01

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 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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo then Caffeine

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).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Other Names:

• Saline

Caffeine

Intervention Type: DRUG

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

Other Names:

• Caffeine citrate

Caffeine then Placebo

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).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Other Names:

• Saline

Caffeine

Intervention Type: DRUG

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

Other Names:

• Caffeine citrate

Interventions

Placebo

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

Other Names:

• Saline

Intervention Type: DRUG

Caffeine

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

Other Names:

• Caffeine citrate

Intervention Type: DRUG

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01GM116119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB17-1174

Identifier Type: -

Identifier Source: org_study_id