Breath Gas Measurement of Propofol During Anesthesia in P... | NCT01835340

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

NCT01835340

Sponsor

University of Luebeck

Status

Completed

Last Update Posted

Dec 12, 2017Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Urological Disease

Interventions

Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 9, 2017Actual

Completion Date

Dec 9, 2017Actual

First Submitted Date

Apr 15, 2013

First Submission Date that Met QC Criteria

Apr 17, 2013

First Posted Date

Apr 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2017

Last Update Posted Date

Dec 12, 2017Actual

Name	Class
Draeger	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propofol	Experimental	Propofol Patients will receive propofol anesthesia on the study day	Device: Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.	Device		propofol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hartmut Gehring, Professor	University of Luebeck	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anesthesiology and Intensive Care		Lübeck	Schleswig-Holstein	23538	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19336539	Background	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.

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases