LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass (LISRACC)

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.

Study Overview

• Status: Completed
• Conditions: Opioid Free Anaesthesia; Opioid Anaesthesia
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 1772

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • CHU Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgical

Description

Inclusion Criteria:

age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021

Exclusion Criteria:

LVAD Heart transplantation Incomplete data in relation to outcomes

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opioid free anaesthesia; patient anesthtesized with lidocaine	Other: Data collection; complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay
Opioid anaesthesia; patients anesthetized with sufentanil	Other: Data collection; complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stays (days)	Total stay in ICU in day	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	cardiac, neurological, renal, respiratory, red blood transfusion	Day 30
Hospital stays (days)	hospital stay	Day 30

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ACTUAL): January 15, 2022
• Study Completion (ACTUAL): January 15, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GUINOT 2021-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No