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CompletedNCT00538421ABSENTUpdated Mar 11, 2013

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

A Phase 4 interventional study of Propofol and Sevoflurane in Aortic Diseases, Abdominal and Aneurysm, sponsored by Sykehuset i Vestfold HF. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-11.

Sponsored by Sykehuset i Vestfold HF · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
193
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Aortic Diseases
  • Abdominal
  • Aneurysm
  • Surgery

Keywords

  • propofol
  • Anaesthesia
  • Sevoflurane
  • Abdominal
  • Aortic
  • Aneurysm
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 193 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Sykehuset i Vestfold HF is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
193 participants (actual)

Study arms

  • Active comparator
    1

    Drug: Propofol

  • Active comparator
    2

    Drug: Sevoflurane

Interventions

  • DrugPropofol

    Infusion intravenously (IV) 0-10 mg/kg/h

  • DrugSevoflurane

    0,7-1,5 MAC

06

Study locations

1 site
  • Sykehuset i Vestfold HF
    Tonsberg, 3103, Norway
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00538421
Lead sponsor
Sykehuset i Vestfold HF
Collaborators
Oslo University Hospital
Responsible party
Espen Lindholm (Chief consultant, Sykehuset i Vestfold HF) — Principal investigator
First posted
Oct 2, 2007
Start date
Mar 2008
Primary completion
Feb 2013
Completion
Mar 2013
Last update
Mar 11, 2013

Study contacts

Espen Lindholm, MD
study director · Sykehuset i Vestfold HF

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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