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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00706277
Other study ID # 2007-007161-25
Secondary ID
Status Completed
Phase Phase 4
First received June 25, 2008
Last updated February 9, 2009
Start date June 2008
Est. completion date December 2008

Study information

Verified date February 2009
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- ASA 1-2

- BMI normal

Exclusion Criteria:

- lung disease

- Nicotine abuse

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
propofol
propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour
propofol
propofol 2mg
remifentanil
remifentanil 0,25mcg/kg/hour
fentanyl
fentanyl 100mcg
Sevoflurane/Nitrous Oxide
maintenance of anesthesia with sevoflurane and nitrous oxide

Locations

Country Name City State
Austria TILAK Hospitals Innsbruck

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary FEV1 forced expiratory volume; FVC forced vital capacity preoperative, 30 minutes postoperative No
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