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Completed

NCT Number: NCT03816592

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Free Anaesthesia

Procedure

patient anesthtesized with lidocaine, ketamine and dexamethasone

Opioid anaesthesia

Procedure

patients anesthetized with sufentanil ketamine and dexamethasone

Primary outcomes

  1. Morphine consumption

    Time frame: Day 2

    Total morphine consumption over the first 48 post operative hours in milligrammes

  2. Complications

    Time frame: Day 7

    composite end point of post operative complications (cardiac, neurological, renal, respiratory)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Acronym: OFACAR 1

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2019
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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