Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue

University of Utah0 sites26 target enrollmentOctober 2013

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: University of Utah
Enrollment: 26
Primary Endpoint: Breath prompting successful rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a small trial to test feasibility of an idea for a potential device. The investigators tested the feasibility of prompting a volunteer to breathe when their breathing had slowed down during administration of anesthetic drugs.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

March 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Utah

Responsible Party

Principal Investigator

Lara Brewer

Research Assistant Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

•American Society of Anesthesia (ASA) Class I and Class II male and female (non-pregnant/non-lactating) volunteers.
•Normal healthy individual as indicated by medical history and a physical examination.
•At least 18 years of age and less than 55 years of age.
•Negative drug screen.
•Uncomplicated airway anatomy.
•A Body Mass Index between 18 and
•Are fully informed of the risks of entering the study and willingly provide written consent to enter the trial.
•Female subjects of child bearing potential will have a negative urine pregnancy test on the day the study is conducted.

Exclusion Criteria

•Known or suspected neurological pathologies.
•A history of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter the pharmacokinetics or pharmacodynamics of remifentanil and propofol.
•Known obstructive sleep apnea.
•Known or suspected hypersensitivity to any compound present in the study.
•Any potential subject suffering from medical problems that, in the judgment of the investigator, presents unacceptable risk to the volunteer are not eligible for enrollment.
•Vulnerable subject groups such as prisoners and the mentally disabled that are traditionally excluded from medical research are also excluded.
•The potential subject has taken any medication within 2 days prior to chosen drug administration, with the exception of oral contraceptives.
•The potential subject is wearing artificial nails.
•A positive urine pregnancy test (females only)
•Female subjects who are currently lactating \& breast-feeding.