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

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT00538421
First received: October 1, 2007
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Aortic Diseases
Abdominal
Aneurysm
Surgery
 Drug: Propofol
Drug: Sevoflurane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sykehuset i Vestfold HF:

Enrollment: 193
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Propofol
Infusion intravenously (IV) 0-10 mg/kg/h
Active Comparator: 2 Drug: Sevoflurane
0,7-1,5 MAC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538421

Locations
Norway
Sykehuset i Vestfold HF
Tonsberg, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
Oslo University Hospital
Investigators
Study Director: Espen Lindholm, MD Sykehuset i Vestfold HF
  More Information

No publications provided

Responsible Party: Espen Lindholm, Chief consultant, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT00538421     History of Changes
Other Study ID Numbers: S-07294b (REK), 2007-000002-79 (Eudract), 17089 (NSD)
Study First Received: October 1, 2007
Last Updated: March 8, 2013
Health Authority: 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:
propofol
Anaesthesia
Sevoflurane
 Abdominal
Aortic
Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Diseases
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Propofol
Sevoflurane
Remifentanil
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013