A Study to Determine if Caffeine Accelerates Emergence From Anesthesia

NCT02567968 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB15-08971R01GM116119-01
• 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 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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Waking Time - Re-establishment of the Gag Reflex.

  The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a "gag response" in all test subjects. This objective and unequivocal measurement constituted the "emergence" time for each subject. The "emergence" time was defined as the time between terminating the anesthesia and the test subject starting to gag.

  followed from the end of anesthesia to gag reflex, up to 2 hours

Secondary Outcomes (8)

• Cognitive Test1 - Visual Analog Scale --- Feel Good

  Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.

• Cognitive Test1 - Visual Analog Scale --- Feel Bad

  Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.

• Cognitive Test2 - Sternberg Test of Memory

  Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.

• Cognitive Test3 - Divided Attention Task

  Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.

• Bispectral Index

  Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo Control

Caffeine

ACTIVE COMPARATOR

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.

Drug: Caffeine

Interventions

Caffeine DRUG

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

Also known as: Caffeine citrate

Caffeine

Placebo Control DRUG

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

Also known as: Saline

Placebo

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 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; caffeine citrate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Aaron Fox, PhD
• Organization: University of Chicago

aaronfox@uchicago.edu

7737020021

Study Officials

• Aaron Fox, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 5, 2015
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 16, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-07

Locations

US (1)