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

NCT ID: NCT01835340

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-09

Brief Summary

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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.

Detailed Description

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Conditions

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Urological Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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propofol

Propofol Patients will receive propofol anesthesia on the study day

Group Type EXPERIMENTAL

Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.

Intervention Type DEVICE

Interventions

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Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Draeger

UNKNOWN

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Martin Grossherr

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hartmut Gehring, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

Locations

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Dept. of Anesthesiology and Intensive Care

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19336539 (View on PubMed)

Other Identifiers

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NCT01835340

Identifier Type: -

Identifier Source: org_study_id

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