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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT03215446

Collaborator

(none)

164

Enrollment

Location

Arms

28.2

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vascular Surgery	Drug: maintenance of anaesthesia with propofol Drug: maintenance of anaesthesia with sevoflurane	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 13, 2016

Actual Primary Completion Date :

May 29, 2018

Actual Study Completion Date :

Oct 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: propofol	Drug: maintenance of anaesthesia with propofol
Experimental: sevoflurane	Drug: maintenance of anaesthesia with sevoflurane

Arm

Intervention/Treatment

Active Comparator: propofol

Drug: maintenance of anaesthesia with propofol

Experimental: sevoflurane

Drug: maintenance of anaesthesia with sevoflurane

Outcome Measures

Primary Outcome Measures

change from baseline Creatine PhosphoKinase [up to 24 hours post surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT03215446

Other Study ID Numbers:

STEINBERG-GIRARD 2015

First Posted:

Jul 12, 2017

Last Update Posted:

Jan 25, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Propofol

Sevoflurane

Study Results

No Results Posted as of Jan 25, 2021