Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery

Phase 4

Completed

• Conditions: Vascular Surgery
• Interventions: Drug: maintenance of anaesthesia with propofol; Drug: maintenance of anaesthesia with sevoflurane

• Registration Number: NCT03215446
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-13
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Primary Completion: 2018-05-29
• Study Completion: 2018-10-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	maintenance of anaesthesia with propofol	-
sevoflurane	maintenance of anaesthesia with sevoflurane	-

Primary Outcome Measures

Name	Time	Method
change from baseline Creatine PhosphoKinase	up to 24 hours post surgery

Trial Locations

Locations (1)

CHU dijon Bourgogne; 🇫🇷 Dijon, France