Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function - Full Text View

Sponsored by:	Medical University Innsbruck
Information provided by:	Medical University Innsbruck
ClinicalTrials.gov Identifier:	NCT00706277

Purpose

The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general anesthesia.

Condition	Intervention	Phase
Lung Function	Drug: propofol, remifentanil Drug: propofol, fentanyl, sevoflurane, nitrous oxide	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Fentanyl Citrate Fentanyl Propofol Sevoflurane Remifentanil Remifentanil hydrochloride Nitrous oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:

FEV1 forced expiratory volume FVC forced vital capacity [ Time Frame: preoperative, 30 postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TIVA: Active Comparator patients receiving total intravenous anesthesia (TIVA)	Drug: propofol, remifentanil propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour and remifentanil 0,25mcg/kg/hour
balanced: Active Comparator patients receiving balanced anesthesia	Drug: propofol, fentanyl, sevoflurane, nitrous oxide propofol 2mg and fentanyl 100mcg for induction of anesthesia; maintenance of anesthesia with sevoflurane and nitrous oxide.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA 1-2
BMI normal

Exclusion Criteria:

lung disease
Nicotine abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706277

Contacts

Contact: Arnulf Benzer, MD

43-504-512-28503

arnulf.benzer@uki.at

Locations

Austria
TILAK Hospitals	Recruiting
Innsbruck, Austria, 6020
Principal Investigator: Arnulf Benzer, MD

Sponsors and Collaborators

Medical University Innsbruck

Investigators

Principal Investigator:

Arnulf Benzer, MD

TILAK Hospitals

More Information

Publications:

Gunnarsson L, Lindberg P, Tokics L, Thorstensson O, Thörne A. Lung function after open versus laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1995 Apr;39(3):302-6.

Regli A, von Ungern-Sternberg BS, Reber A, Schneider MC. Impact of spinal anaesthesia on peri-operative lung volumes in obese and morbidly obese female patients. Anaesthesia. 2006 Mar;61(3):215-21.

Natalini G, Franceschetti ME, Pletti C, Recupero D, Lanza G, Bernardini A. Impact of laryngeal mask airway and tracheal tube on pulmonary function during the early postoperative period. Acta Anaesthesiol Scand. 2002 May;46(5):525-8.

Responsible Party:	TILAK A-6020 Innsbruck, Anichstr. 35 AUSTRIA ( Arnulf Benzer )
Study ID Numbers:	2007-007161-25
Study First Received:	June 25, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00706277
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University Innsbruck:

forced vital capacity
forced expired volume in 1 s

Study placed in the following topic categories:

Fentanyl
Remifentanil
Nitrous Oxide
Propofol
Sevoflurane

Additional relevant MeSH terms:

Anesthetics, Intravenous
Hematologic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, Inhalation
Analgesics, Non-Narcotic

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009