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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Opioid Anaesthesia
Opioid Free Anaesthesia

Treatments

Procedure: Opioid anaesthesia
Procedure: Opioid free anaesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT03816592
GUINOT 2019

Details and patient eligibility

About

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).

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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