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

Urological Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835340
• Other study ID #: NCT01835340
• Status: Completed
• Phase: N/A
• First received: April 15, 2013
• Last updated: December 9, 2017
• Start date: October 2012
• Est. completion date: December 9, 2017

Study information

• Verified date: December 2017
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 9, 2017
• Est. primary completion date: December 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urologic Diseases
• Urological Disease

Intervention

Device:
• Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.

Locations

Country	Name	City	State
Germany	Dept. of Anesthesiology and Intensive Care	Luebeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	Draeger

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled propofol (parts per billion)		Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia