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Clinical Trials/NCT01191021
NCT01191021
Completed
Phase 1

Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations

University of California, San Francisco1 site in 1 country20 target enrollmentAugust 2010
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ConditionsGeneral Anesthesia
InterventionsPropofol Anesthesia
DrugsPropofol Anesthesia

Overview

Phase
Phase 1
Intervention
Propofol Anesthesia
Conditions
General Anesthesia
Sponsor
University of California, San Francisco
Enrollment
20
Locations
1
Primary Endpoint
Exhaled propofol (parts per billion)
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
October 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • •Anesthesia within 6 months
  • •Known drug allergies
  • •History of adverse events during general anesthesia

Arms & Interventions

Propofol

Volunteers will receive propofol anesthesia on the study day.

Intervention: Propofol Anesthesia

Outcomes

Primary Outcomes

Exhaled propofol (parts per billion)

Time Frame: Continuous measurement over 90 min

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

Time Frame: continuous over 90 min

Study Sites (1)

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