Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures

December 9, 2017 updated by: Martin Grossherr, University of Luebeck

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Dept. of Anesthesiology and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: propofol
Propofol Patients will receive propofol anesthesia on the study day
Device: Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exhaled propofol (parts per billion)
Time Frame: Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia
Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

Draeger

Investigators

  • Principal Investigator: Hartmut Gehring, Professor, University of Luebeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 9, 2017

Study Completion (Actual)

December 9, 2017

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 9, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT01835340

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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