Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

NCT03816592 | Completed

• 1 other identifier: GUINOT 2019
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Opioid Free Anaesthesia; Opioid Anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Opioid free anaesthesia

patient anesthtesized with lidocaine, ketamine and dexamethasone

Procedure: Opioid free anaesthesia

Opioid anaesthesia

patients anesthetized with sufentanil ketamine and dexamethasone

Procedure: Opioid anaesthesia

Interventions

Opioid free anaesthesia PROCEDURE

patient anesthtesized with lidocaine, ketamine and dexamethasone

Opioid free anaesthesia

Opioid anaesthesia PROCEDURE

patients anesthetized with sufentanil ketamine and dexamethasone

Opioid anaesthesia

Eligibility Criteria

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

Study Population

Cardiac surgical

You may qualify if:

• age over 18 years
• cardiac surgery with cardiopulmonary bypass

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 31366330 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: January 1, 2019
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)