Monitoring Exhaled Propofol to Individualize General Anesthesia

Phase 1

Completed

• Conditions: General Anesthesia
• Interventions: Drug: Propofol Anesthesia

• Registration Number: NCT01191021
• Lead Sponsor: University of California, San Francisco

Brief Summary

This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath, blood and drug effect in volunteers undergoing general anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model for propofol in exhaled breath.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-20
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-30
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18 years of age

  • Written informed consent
  • Ability and willingness to give written informed consent
  • American Society of Anesthesiologists (ASA) risk score I

Exclusion Criteria

• Volunteers ASA physical status II - III
• Pregnancy
• Volunteers with history of neurological disease or stroke
• Volunteers with a history of recreational drug abuse
• Volunteers with a history of alcohol abuse
• Smokers
• Anesthesia within 6 months
• Known drug allergies
• History of adverse events during general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol Anesthesia	Volunteers will receive propofol anesthesia on the study day.

Primary Outcome Measures

Name	Time	Method
Exhaled propofol (parts per billion)	Continuous measurement over 90 min
Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia	continuous over 90 min

Trial Locations

Locations (1)

Department of Anesthesia and Perioperative Care, UCSF; 🇺🇸 San Francisco, California, United States