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

Sponsor

Sykehuset i Vestfold HF (Other)

Overall Status

Completed

CT.gov ID

NCT00538421

Collaborator

Oslo University Hospital (Other)

193

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases Abdominal Aneurysm Surgery	Drug: Propofol Drug: Sevoflurane	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

193 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Propofol Infusion intravenously (IV) 0-10 mg/kg/h
Active Comparator: 2	Drug: Sevoflurane 0,7-1,5 MAC

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Propofol

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

Active Comparator: 2

Drug: Sevoflurane

0,7-1,5 MAC

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.