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Monitoring Exhaled Propofol to Individualize General Anesthesia

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: General Anesthesia

Intervention: Propofol Anesthesia (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Christian C Apfel, MD, PhD, Principal Investigator, Affiliation: Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
Cyrill Hornuss, MD, Principal Investigator, Affiliation: Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco

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.

Clinical Details

Official title: Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Primary outcome:

Exhaled propofol (parts per billion)

Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Department of Anesthesia and Perioperative Care, UCSF, San Francisco, California 94122, United States
Additional Information

Related publications:

Hornuss C, Praun S, Villinger J, Dornauer A, Moehnle P, Dolch M, Weninger E, Chouker A, Feil C, Briegel J, Thiel M, Schelling G. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology. 2007 Apr;106(4):665-74.

Starting date: August 2010
Last updated: June 4, 2013

Page last updated: August 20, 2015

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