Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vascular Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maintenance of anaesthesia with propofol

Drug

maintenance of anaesthesia with sevoflurane

Drug

Primary outcomes

change from baseline Creatine PhosphoKinase

Time frame: up to 24 hours post surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Evaluation of Total (Pre and Post) Conditioning on Rhabdomyolysis of Sedation With Sevoflurane Versus Propofol in Vascular Surgery With Clamping

Acronym: PHAR

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jul 12, 2017
Registry last updated: Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed