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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Diseases Abdominal Aneurysm Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

0,7-1,5 MAC

Interventions

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Propofol

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

Intervention Type DRUG

Sevoflurane

0,7-1,5 MAC

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No