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

Primary Purpose

Aortic Diseases, Abdominal, Aneurysm

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Diseases focused on measuring propofol, Anaesthesia, Sevoflurane, Abdominal, Aortic, Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sykehuset i Vestfold HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 1, 2007
Last Updated
March 8, 2013
Sponsor
Sykehuset i Vestfold HF
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00538421
Brief Title
Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery
Acronym
ABSENT
Official Title
Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Diseases, Abdominal, Aneurysm, Surgery
Keywords
propofol, Anaesthesia, Sevoflurane, Abdominal, Aortic, Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Infusion intravenously (IV) 0-10 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
0,7-1,5 MAC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Espen Lindholm, MD
Organizational Affiliation
Sykehuset i Vestfold HF
Official's Role
Study Director
Facility Information:
Facility Name
Sykehuset i Vestfold HF
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway

12. IPD Sharing Statement

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

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