Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery

Vascular Surgery Clinical Trial

— PHAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215446
• Other study ID #: STEINBERG-GIRARD 2015
• Status: Completed
• Phase: Phase 4
• Start date: June 13, 2016
• Est. completion date: October 19, 2018

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 19, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Surgery

Intervention

Drug:
• maintenance of anaesthesia with propofol

• maintenance of anaesthesia with sevoflurane

Locations

Country	Name	City	State
France	CHU dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline Creatine PhosphoKinase		up to 24 hours post surgery