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Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function

This study has been completed.
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00706277
First received: June 25, 2008
Last updated: February 9, 2009
Last verified: February 2009
History of Changes
  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
Drug: remifentanil
Drug: fentanyl
Drug: Sevoflurane/Nitrous Oxide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • FEV1 forced expiratory volume; FVC forced vital capacity [ Time Frame: preoperative, 30 minutes postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Study Completion Date: December 2008
Arms Assigned Interventions
Active Comparator: TIVA
patients receiving total intravenous anesthesia (TIVA)
 Drug: propofol
propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour
Drug: remifentanil
remifentanil 0,25mcg/kg/hour
Active Comparator: balanced
patients receiving balanced anesthesia
 Drug: propofol
propofol 2mg
Drug: fentanyl
fentanyl 100mcg
Drug: Sevoflurane/Nitrous Oxide
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

Locations
Austria
TILAK Hospitals
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Arnulf Benzer, MD TILAK Hospitals
  More Information

Publications:

Responsible Party: Arnulf Benzer, TILAK A-6020 Innsbruck, Anichstr. 35 AUSTRIA
ClinicalTrials.gov Identifier: NCT00706277     History of Changes
Other Study ID Numbers: 2007-007161-25
Study First Received: June 25, 2008
Last Updated: February 9, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University Innsbruck:
forced vital capacity
forced expired volume in 1 s

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Nitrous Oxide
Propofol
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
 Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Analgesics, Non-Narcotic
Anesthetics, Inhalation
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on June 17, 2013