Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery

NCT03215446 | Completed Phase 4

• 1 other identifier: STEINBERG-GIRARD 2015
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Conditions

Vascular Surgery

Outcome Measures

Primary Outcomes (1)

• change from baseline Creatine PhosphoKinase

  up to 24 hours post surgery

Study Arms (2)

propofol

ACTIVE COMPARATOR

Drug: maintenance of anaesthesia with propofol

sevoflurane

EXPERIMENTAL

Drug: maintenance of anaesthesia with sevoflurane

Interventions

maintenance of anaesthesia with propofol DRUG

propofol

maintenance of anaesthesia with sevoflurane DRUG

sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 12, 2017
• Study Start: June 13, 2016
• Primary Completion: May 29, 2018
• Study Completion: October 19, 2018
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)