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

• Sponsor: University of Luebeck (Other)
• Overall Status: Completed
• CT.gov ID: NCT01835340
• Collaborator: Draeger (Other)
• Enrollment: 22
• Location: 1
• Arm: 1
• Duration (Months): 62.3
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urological Disease	Device: Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 9, 2017
• Actual Study Completion Date: Dec 9, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Exhaled propofol (parts per billion) [Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anesthesiology and Intensive Care	Luebeck	Schleswig-Holstein	Germany	23538

Sponsors and Collaborators

• University of Luebeck
• Draeger

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Martin Grossherr, PhD, MD, University of Luebeck
• ClinicalTrials.gov Identifier: NCT01835340
• Other Study ID Numbers: NCT01835340
• First Posted: Apr 18, 2013
• Last Update Posted: Dec 12, 2017
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Urologic Diseases; Anesthetics; Propofol

Study Results

No Results Posted as of Dec 12, 2017