Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery (ABSENT)
This study has been completed.
Oslo University Hospital
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF
First received: October 1, 2007
Last updated: March 8, 2013
Last verified: March 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
Active Comparator: 1
Infusion intravenously (IV) 0-10 mg/kg/h
Active Comparator: 2
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients who are planned for open, elective abdominal aortic aneurysm surgery.
- ASA group 1-4.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538421
|Sykehuset i Vestfold HF
|Tonsberg, Norway, 3103 |
Sykehuset i Vestfold HF
Oslo University Hospital
||Espen Lindholm, MD
||Sykehuset i Vestfold HF
No publications provided
||Espen Lindholm, Chief consultant, Sykehuset i Vestfold HF
History of Changes
|Other Study ID Numbers:
||S-07294b (REK), 2007-000002-79 (Eudract), 17089 (NSD)
|Study First Received:
||October 1, 2007
||March 8, 2013
||Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Keywords provided by Sykehuset i Vestfold HF:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 30, 2015
Aortic Aneurysm, Abdominal
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Peripheral Nervous System Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents