Aortic DiseasesPhase 4ABSENTNCT00538421
Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery
A Phase 4 study testing Propofol and Sevoflurane in people with Aortic Diseases and Abdominal, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Abdominal, Aneurysm
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2008to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are planned for open, elective abdominal aortic aneurysm surgery.
- ASA group 1-4.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery
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.
- Conditions
- Aortic Diseases, Abdominal, Aneurysm, Surgery
- Being tested
- Propofol, Sevoflurane
- Keywords
- propofol, Anaesthesia, Sevoflurane, Abdominal, Aortic, Aneurysm
- Medical subject headings
- Aortic Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Infusion intravenously (IV) 0-10 mg/kg/h
SevofluraneDrug
0,7-1,5 MAC
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Propofol |
| 2 | Active comparator | Not described Receives: Drug: Sevoflurane |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startMar 2008
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Espen Lindholm, Sykehuset i Vestfold HF
- Investigators
- Espen Lindholm, MD, Study director, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538421
- Sponsor's protocol ID
- S-07294b (REK)
- Other IDs
- 2007-000002-79 (Eudract), 17089 (NSD)
- Acronym
- ABSENT
- Status last verified
- Mar 2013
- First submitted
- 1 Oct 2007
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery
- ClinicalTrials.gov ID
- NCT00538421
- Acronym / sponsor ID
- ABSENT / S-07294b (REK)
- Conditions
- Aortic Diseases, Abdominal, Aneurysm, Surgery
- Keywords
- propofol, Anaesthesia, Sevoflurane, Abdominal, Aortic, Aneurysm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Mar 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Propofol |
| 2 | Active comparator | Drug: Sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are planned for open, elective abdominal aortic aneurysm surgery.
- ASA group 1-4.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolInfusion intravenously (IV) 0-10 mg/kg/h | Drug | 1 |
| Sevoflurane0,7-1,5 MAC | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen Lindholm, MD study director
Sykehuset i Vestfold HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Sevoflurane in people with Aortic Diseases and Abdominal, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.