Opioid-potentiated Volative Anaesthetic Vs. Remifentanil... | NCT00538421

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

NCT00538421

Sponsor

Sykehuset i Vestfold HF

Status

Completed

Last Update Posted

Mar 11, 2013Estimated

Enrollment

193Actual

Phase

Phase 4

Conditions

Aortic Diseases
Abdominal
Aneurysm
Surgery

Interventions

Propofol
Sevoflurane

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Feb 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Oct 1, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2013

Last Update Posted Date

Mar 11, 2013Estimated

Name	Class
Oslo University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

193Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Propofol
2	Active Comparator		Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Infusion intravenously (IV) 0-10 mg/kg/h	1
Sevoflurane

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Espen Lindholm, MD	Sykehuset i Vestfold HF	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset i Vestfold HF		Tønsberg		3103	Norway

Condition Browse Module

MeSH Terms

ID	Term
D001018	Aortic Diseases
D000783	Aneurysm

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
2007-000002-79 (Eudract)
17089 (NSD)