Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery (PHAR)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 4

Conditions

Vascular Surgery

Treatments

Drug: maintenance of anaesthesia with sevoflurane

Drug: maintenance of anaesthesia with propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT03215446

STEINBERG-GIRARD 2015

Details and patient eligibility

About

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

Enrollment

164 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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