NCT00538421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

4.9 years

First QC Date

October 1, 2007

Last Update Submit

March 8, 2013

Conditions

Aortic DiseasesAbdominalAneurysmSurgery

Keywords

propofolAnaesthesiaSevofluraneAbdominalAorticAneurysm

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Propofol

2

ACTIVE COMPARATOR
Drug: Sevoflurane

Interventions

PropofolDRUG

Infusion intravenously (IV) 0-10 mg/kg/h

1
SevofluraneDRUG

0,7-1,5 MAC

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are planned for open, elective abdominal aortic aneurysm surgery.
  • ASA group 1-4.

You may not qualify if:

  • 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.
  • Acute abdominal aortic surgery. Acute dissection or rupture.
  • Planned laparoscopic abdominal aortic aneurysm surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset i Vestfold HF

Tønsberg, 3103, Norway

Location

MeSH Terms

Conditions

Aortic DiseasesAneurysm

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Espen Lindholm, MD

    Sykehuset i Vestfold HF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief consultant

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

March 1, 2008

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

NO(1)