Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery (ABSENT)

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT00538421
First received: October 1, 2007
Last updated: March 8, 2013
Last verified: March 2013

October 1, 2007
March 8, 2013
March 2008
February 2013   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00538421 on ClinicalTrials.gov Archive Site
Not Provided
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Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery
Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery

Comparing 2 different anaesthetic methods during abdominal aortic aneurysm surgery. The patients will be followed up 30 days postoperative. Number of patients included will be 200. Perioperative details will be analyzed.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Diseases
  • Abdominal
  • Aneurysm
  • Surgery
  • Drug: Propofol
    Infusion intravenously (IV) 0-10 mg/kg/h
  • Drug: Sevoflurane
    0,7-1,5 MAC
  • Active Comparator: 1
    Intervention: Drug: Propofol
  • Active Comparator: 2
    Intervention: Drug: Sevoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
March 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are planned for open, elective abdominal aortic aneurysm surgery.
  • ASA group 1-4.

Exclusion Criteria:

  • Patients below 18 years.
  • Patients who are included in other pharmaceutical studies.
  • Opioids-, benzodiazepins-, antiepileptic drugs-, alcohol- and α2-agonists abuse.
  • Pregnant and breastfeeding women.
  • Patients with familiar history of malignant hyperthermia.
  • Patients with known hypersensitivity for opioids, propofol or volative anaesthetics.
  • Patients with considerable arrythmia (atrial fibrillation /atrial flutter is acceptable). Uncontrolled hypertension, serious psychiatric disease.
  • Patients with unstable angina pectoris or myocardial infarction last month before inclusion.
  • Acute abdominal aortic surgery. Acute dissection or rupture.
  • Planned laparoscopic abdominal aortic aneurysm surgery.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00538421
S-07294b (REK), 2007-000002-79 (Eudract), 17089 (NSD)
No
Espen Lindholm, Sykehuset i Vestfold HF
Sykehuset i Vestfold HF
Oslo University Hospital
Study Director: Espen Lindholm, MD Sykehuset i Vestfold HF
Sykehuset i Vestfold HF
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP