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

S

Sykehuset i Vestfold HF

Status and phase

Completed
Phase 4

Conditions

Aneurysm
Abdominal
Surgery
Aortic Diseases

Treatments

Drug: Propofol
Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT00538421
2007-000002-79 (Eudract)
S-07294b (REK)
17089 (NSD)

Details and patient eligibility

About

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.

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

193 participants in 2 patient groups

1
Active Comparator group
Treatment:
Drug: Propofol
2
Active Comparator group
Treatment:
Drug: Sevoflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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