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

NCT00706277 | Completed Phase 4

• 1 other identifier: 2007-007161-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Function

Keywords

forced vital capacity; forced expired volume in 1 s

Outcome Measures

Primary Outcomes (1)

• FEV1 forced expiratory volume; FVC forced vital capacity

  preoperative, 30 minutes postoperative

Study Arms (2)

TIVA

ACTIVE COMPARATOR

patients receiving total intravenous anesthesia (TIVA)

Drug: propofol; Drug: remifentanil

balanced

ACTIVE COMPARATOR

patients receiving balanced anesthesia

Drug: propofol; Drug: fentanyl; Drug: Sevoflurane/Nitrous Oxide

Interventions

propofol DRUG

propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour

TIVA

remifentanil DRUG

remifentanil 0,25mcg/kg/hour

TIVA

fentanyl DRUG

fentanyl 100mcg

balanced

Sevoflurane/Nitrous Oxide DRUG

maintenance of anesthesia with sevoflurane and nitrous oxide

balanced

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1-2
• BMI normal

You may not qualify if:

• lung disease
• Nicotine abuse

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

TILAK Hospitals

Innsbruck, 6020, Austria

Location

Related Publications (3)

• Gunnarsson L, Lindberg P, Tokics L, Thorstensson O, Thorne A. Lung function after open versus laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1995 Apr;39(3):302-6. doi: 10.1111/j.1399-6576.1995.tb04066.x.

  PMID: 7793205 BACKGROUND

• 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. doi: 10.1111/j.1365-2044.2005.04441.x.

  PMID: 16480344 BACKGROUND

• 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. doi: 10.1034/j.1399-6576.2002.460509.x.

  PMID: 12027846 BACKGROUND

MeSH Terms

Interventions

Propofol; Remifentanil; Fentanyl; Sevoflurane; Nitrous Oxide

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Arnulf Benzer, MD

  TILAK Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 10, 2009

Record last verified: 2009-02

Locations

AU (1)