Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

NCT ID: NCT03816592

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-03-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Opioid free anaesthesia

patient anesthtesized with lidocaine, ketamine and dexamethasone

Opioid free anaesthesia

Intervention Type: PROCEDURE

patient anesthtesized with lidocaine, ketamine and dexamethasone

Opioid anaesthesia

patients anesthetized with sufentanil ketamine and dexamethasone

Opioid anaesthesia

Intervention Type: PROCEDURE

patients anesthetized with sufentanil ketamine and dexamethasone

Interventions

Opioid free anaesthesia

patient anesthtesized with lidocaine, ketamine and dexamethasone

Intervention Type: PROCEDURE

Opioid anaesthesia

patients anesthetized with sufentanil ketamine and dexamethasone

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31366330 (View on PubMed)

Other Identifiers

GUINOT 2019

Identifier Type: -

Identifier Source: org_study_id