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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538421
First Posted: October 2, 2007
Last Update Posted: March 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF
  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
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

Resource links provided by NLM:


Further study details as provided by Espen Lindholm, 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Submitted: October 1, 2007
First Posted: October 2, 2007
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Espen Lindholm, Sykehuset i Vestfold HF:
propofol
Anaesthesia
Sevoflurane
Abdominal
Aortic
Aneurysm

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