Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

Opioid Free Anaesthesia Clinical Trial

— OFACAR 1  

Official title:

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816592
• Other study ID #: GUINOT 2019
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Anaesthesia
• Opioid Free Anaesthesia

Intervention

Procedure:
• Opioid free anaesthesia
patient anesthtesized with lidocaine, ketamine and dexamethasone
• Opioid anaesthesia
patients anesthetized with sufentanil ketamine and dexamethasone

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

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