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Clinical Trials/NCT01835340
NCT01835340
Completed
Not Applicable

Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients

University of Luebeck1 site in 1 country22 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urological Disease
Sponsor
University of Luebeck
Enrollment
22
Locations
1
Primary Endpoint
Exhaled propofol (parts per billion)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Target controlled infusion technique is used to deliver adequate propofol concentration in plasma.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
December 9, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Luebeck
Responsible Party
Principal Investigator
Principal Investigator

Martin Grossherr

PhD, MD

University of Luebeck

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-II

Exclusion Criteria

  • Denial of the patient
  • Patients ASA physical status III- IV
  • Pregnancy
  • Volunteers with history of neurological disease or stroke
  • Volunteers with a history of recreational drug abuse
  • Volunteers with a history of alcohol abuse
  • Known drug allergies
  • History of adverse events during general anesthesia
  • Total intravenous anesthesia not practicable

Outcomes

Primary Outcomes

Exhaled propofol (parts per billion)

Time Frame: Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia

Study Sites (1)

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