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

February 9, 2009 updated by: Medical University Innsbruck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • TILAK Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-2
  • BMI normal

Exclusion Criteria:

  • lung disease
  • Nicotine abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: propofol
propofol 2mg
Drug: remifentanil
remifentanil 0,25mcg/kg/hour
Active Comparator: balanced
patients receiving balanced anesthesia
Drug: propofol
propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour
Drug: propofol
propofol 2mg
Drug: fentanyl
fentanyl 100mcg
Drug: Sevoflurane/Nitrous Oxide
maintenance of anesthesia with sevoflurane and nitrous oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 forced expiratory volume; FVC forced vital capacity
Time Frame: preoperative, 30 minutes postoperative
preoperative, 30 minutes postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Arnulf Benzer, MD, TILAK Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (Estimate)

June 27, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-007161-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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