Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

Completed

• Conditions: Opioid Anaesthesia; Opioid Free Anaesthesia
• Interventions: Procedure: Opioid anaesthesia; Procedure: Opioid free anaesthesia

• Registration Number: NCT03816592
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Opioid anaesthesia	Opioid anaesthesia	patients anesthetized with sufentanil ketamine and dexamethasone
Opioid free anaesthesia	Opioid free anaesthesia	patient anesthtesized with lidocaine, ketamine and dexamethasone

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France