Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular 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

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-13

Study Completion Date

2018-10-19

Brief Summary

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Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class effect, and Sevoflurane is the most widely used today.

In humans, the protective effects of halogenated agents have principally been studied in heart surgery and have shown encouraging clinical results. It seems that HAA induce both pre-conditioning of the myocardium (early and late) and post conditioning.

Given these protective effects of HAA, in 2007, the American Heart Association (AHA) recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients with a high cardio-vascular risk. The aim of this study is to show a decrease in rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane anaesthesia, in the post-operative period following vascular surgery with clamping

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Detailed Description

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Conditions

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Vascular Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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propofol

Group Type ACTIVE_COMPARATOR

maintenance of anaesthesia with propofol

Intervention Type DRUG

sevoflurane

Group Type EXPERIMENTAL

maintenance of anaesthesia with sevoflurane

Intervention Type DRUG

Interventions

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maintenance of anaesthesia with propofol

Intervention Type DRUG

maintenance of anaesthesia with sevoflurane

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* persons who have provided written consent
* patients over 18 years of age
* patients undergoing scheduled vascular surgery with high clamping for:
* Abdominal aortic aneurysm
* suprapopliteal vascular bypass (aorto-bi-femoral, femoral trifurcation, ilio-femoral or femoro-femoral, femoro-popliteal).

Exclusion Criteria

* persons without health insurance cover
* patients younger than 18 years of age, pregnant or breast-feeding women and adults under guardianship
* patients with epilepsy
* emergency surgery
* patient presenting a contra-indication for Sevoflurane: hypersensitivity to sevoflurane or to other halogenated anaesthetic agents, myopathy, hyper-eosinophilia, immunoallergic hepatitis, known or suspected genetic predisposition to malignant hyperthermia
* patients presenting a contra-indication to the use of Propofol: known hypersensitivity to propofol or to one of the constituents of the product, allergy to peanuts or soja
* Patients presenting a contra-indication for sufentanil: hypersensitivity to sufentanil or to opioids
* Association with opioid agonists-antagonists or partial opioid antagonists
* patients presenting a CI for the use of Cisatracurium: history of allergy or hypersensitivity to cisatracurium or atracurium
* patients presenting cardiac, respiratory, renal or kidney failure, hypovolemia, poor general health
* Patients with a risl of prolongation of the QT interval
* Patients with end-stage renal failure - requiring dialysis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No