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

Surgery Clinical Trial

— ABSENT  

Official title:

Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538421
• Other study ID #: S-07294b (REK)
• Secondary ID: 2007-000002-79 (
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2007
• Last updated: March 8, 2013
• Start date: March 2008
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a2-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases
• Surgery

Intervention

Drug:
• Propofol
Infusion intravenously (IV) 0-10 mg/kg/h
• Sevoflurane
0,7-1,5 MAC

Locations

Country	Name	City	State
Norway	Sykehuset i Vestfold HF	Tonsberg

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	Oslo University Hospital

Country where clinical trial is conducted

Norway,