Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass (OFACAR 1)

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay).

Study Overview

• Status: Completed
• Conditions: Opioid Free Anaesthesia; Opioid Anaesthesia
• Intervention / Treatment: Procedure: Opioid free anaesthesia; Procedure: Opioid anaesthesia

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

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

Exclusion Criteria:

• patient with chronic analgesia treatment
• patient on antidepressive therapy
• gabapentin use
• preoperative cognitive dysfunction
• patient treated with zyvoxid

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opioid free anaesthesia; patient anesthtesized with lidocaine, ketamine and dexamethasone	Procedure: Opioid free anaesthesia; patient anesthtesized with lidocaine, ketamine and dexamethasone
Opioid anaesthesia; patients anesthetized with sufentanil ketamine and dexamethasone	Procedure: Opioid anaesthesia; patients anesthetized with sufentanil ketamine and dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Total morphine consumption over the first 48 post operative hours in milligrammes	Day 2
Complications	composite end point of post operative complications (cardiac, neurological, renal, respiratory)	Day 7

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: GUINOT 2019

Drug and device information, study documents

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