A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

NCT03360903 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB17-11741R01GM116119
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes

Secondary Outcomes (6)

• Cognitive Test1 - Visual Analog Scale

  Up to 120 minutes after terminating anesthesia.

• Cognitive Test2 - Sternberg Test of Memory

  Up to 120 minutes after terminating anesthesia.

• Cognitive Test3 - Divided Attention Task

  Up to 120 minutes after terminating anesthesia.

• Bispectral Index

  Up to 120 minutes after terminating anesthesia.

• Mean Arterial Blood Pressure

  Up to 120 minutes after terminating anesthesia.

Study Arms (2)

Placebo then Caffeine

EXPERIMENTAL

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).

Drug: Placebo; Drug: Caffeine

Caffeine then Placebo

EXPERIMENTAL

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).

Drug: Placebo; Drug: Caffeine

Interventions

Placebo DRUG

Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). Other Names: * Saline

Caffeine then Placebo; Placebo then Caffeine

Caffeine DRUG

Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names: * Caffeine citrate

Caffeine then Placebo; Placebo then Caffeine

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-40.
• Male.
• Normal healthy subject without systematic diseases or conditions.
• Metabolic Equivalents of Functional Capacity \>= 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
• No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
• BMI \< 30 kg/m2.
• No history of prior difficulty with anesthesia.
• No personal or family history of malignant hyperthermia.
• No history of any mental illness.
• No history of drugs or alcohol abuse (urine drug screens required).
• Subjects capable of giving consent.
• Living less than 30 miles away from University of Chicago.
• No history of seizure disorders.
• No history of head trauma.

You may not qualify if:

• Age \<25 or \>40.
• Female.
• ASA physical status \> 1 (normal healthy subject without systematic diseases or conditions)
• Metabolic Equivalents of Functional Capacity (METs) \< 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
• History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
• BMI\>30 kg/m2.
• Prior difficulty with anesthesia.
• Personal or family history of malignant hyperthermia.
• History of any mental illness.
• History of drugs or alcohol abuse (urine drug screens required)
• Subjects not capable of giving consent
• Living more than 30 miles away from University of Chicago.
• History of seizure disorders.
• History of head trauma.

Sponsors & Collaborators

• University of Chicago: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Aaron Fox
• Organization: University of Chicago

aaronfox@uchicago.edu

(773) 702-0021

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 4, 2017
• Study Start: January 2, 2018
• Primary Completion: December 31, 2018
• Study Completion: June 1, 2019
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

US (1)