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

Primary Purpose

Urological Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urological Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Anesthesiology and Intensive Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

propofol

Arm Description

Propofol Patients will receive propofol anesthesia on the study day

Outcomes

Primary Outcome Measures

Exhaled propofol (parts per billion)

Secondary Outcome Measures

Full Information

First Posted
April 15, 2013
Last Updated
December 9, 2017
Sponsor
University of Luebeck
Collaborators
Draeger
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1. Study Identification

Unique Protocol Identification Number
NCT01835340
Brief Title
Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures
Official Title
Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 9, 2017 (Actual)
Study Completion Date
December 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
Draeger

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urological Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propofol
Arm Type
Experimental
Arm Description
Propofol Patients will receive propofol anesthesia on the study day
Intervention Type
Device
Intervention Name(s)
Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.
Primary Outcome Measure Information:
Title
Exhaled propofol (parts per billion)
Time Frame
Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Gehring, Professor
Organizational Affiliation
University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Anesthesiology and Intensive Care
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19336539
Citation
Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Igl BW, Ziegler A, Schmucker P, Gehring H. Propofol concentration in exhaled air and arterial plasma in mechanically ventilated patients undergoing cardiac surgery. Br J Anaesth. 2009 May;102(5):608-13. doi: 10.1093/bja/aep053. Epub 2009 Mar 31.
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Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures

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