Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03215446

Acronym

PHAR

Enrollment

164

Registered

2017-07-12

Start date

2016-06-13

Completion date

2018-10-19

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Surgery

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

Interventions

DRUGmaintenance of anaesthesia with sevoflurane

DRUGmaintenance of anaesthesia with propofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
change from baseline Creatine PhosphoKinase	up to 24 hours post surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026