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NCT Number: NCT04940689

Opioid-Free Anesthesia in Cardiac Surgery

The use of morphine derivatives is widespread for performing general anesthesia. However, opioids have their own side effects: respiratory depression, digestive ileus, cognitive dysfunction, postoperative hyperalgesia, nausea-vomiting or even negative effects on inflammation or adrenal function. The advent of new molecules, with analgesic properties that do not pass through opioid receptors, has allowed the emergence of the concept of anesthesia without morphine (opioid free anesthesia OFA). These molecules are essentially: dexmedetomidine, ketamine, lidocaine. Thus, the use of ketamine is currently recommended in the event of major surgery in order to limit postoperative pain and hyperalgesia. Likewise, the use of dexmedetomidine in place of an opioid during bariatric surgeries has been shown to reduce postoperative pain and intraoperative hemodynamic manifestations. In addition, it would also reduce the incidence of postoperative cognitive dysfunction. A recent meta-analysis even suggested a decrease in length of stay, mechanical ventilation, atrial fibrillation and mortality with the use of dexmedetomidine in the perioperative period. The combined use of various non-morphine analgesic molecules therefore opens the way to anesthesia without morphine, and a French multicenter study on this strategy in general non-cardiac surgery is currently underway. Cardiac surgery is characterized by significant postoperative pain, a high incidence of cognitive dysfunction, and frequent and sometimes significant respiratory complications. An OFA strategy could therefore be beneficial to these patients, but no study has yet addressed the subject.

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Key information

Conditions

Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rouen University Hospital, Rouen, France, Normandy, France

Loading trial locations.

About this study

The objective of our work is therefore to assess the beneficial effects of OFA versus strategy with intraoperative opioids on postoperative complications related to opioids.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients having planned cardiac surgery under cardiopulmonary bypass, with at least one coronary artery bypass grafting and rf at least one internal mammary artery as graft; possible association with aortic valve replacement
  • Patient having red and understood the information letter and signed the consent form
  • For women : of childbearing age, need to confirm the absence of an active pregnancy by a negative blood pregnancy test within 48 hours prior to inclusion / menopausal (amenorrhea not medically induced for at least 12 months before the inclusion visit)
  • Patient affiliated to a social security scheme

Exclusion criteria

  • Preoperative treatment with morphine or its derivatives (including tramadol) in the 15 days preceding the inclusion visit
  • Pre-existing high-degree conduction disorder
  • Bradycardia < 50 bpm
  • Oxygen therapy prior to inclusion
  • Heart failure with LVEF <40%
  • BMI ≥ 35 kg/m²
  • Myocardial suffering in the 5 days preceding inclusion
  • Patient in shock
  • Known adrenal insufficiency and / or long-term systemic corticosteroid treatment (equivalent to hydrocortisone hemisuccinate ≥ 20 mg / day)
  • Combined surgery other than aortic valve
  • Long-term non-invasive ventilation (including for obstructive sleep apnea syndrome)
  • Any antecedent or active practice (s) of drug addiction;
  • Contraindication to one of the experimental and / or non-experimental treatments: dexmedetomidine, lidocaine, dexamethasone, ketamine, remifentanil or morphine
  • Acute cerebrovascular pathology,
  • Severe hepatic insufficiency (factor V level <50%),
  • Pre-existing cognitive disorders,
  • Patient for whom the CAM-ICU questionnaire cannot be carried out (deaf patients for example),
  • Pregnant or parturient or breastfeeding woman
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship
  • Patient participating in another drug trial or having participated in another drug trial within 1 month before randomization

Treatment and study plan

Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg

Drug

The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin.

Other names: experimental

Remifentanil

Drug

The patient will be anesthetized with morphin.

Other names: Control

Primary outcomes

  1. To assess the impact of general anesthesia strategy without the use of opioids (OFA) on the incidence of major postoperative complications related to opioids compared to the reference strategy using opioids.

    Time frame: 48 hours post-surgery

    Composite criterion consisting of the appearance 48 hours after the surgery of an intestinal ileus, and / or of an alteration of the neurological state, and / or of an acute respiratory failure, and / or of a death

Secondary outcomes

  1. To assess the impact of OFA on the incidence of postoperative nausea and vomiting.

    Time frame: 48 hours post-surgery

    Existence of post-surgery nausea

  2. To assess the impact of OFA on the incidence of postsurgery pain.

    Time frame: 48 hours post-surgery

    Number of post-surgery pain episodes at rest (VAS ≥ 3) and total morphine consumption

  3. To assess the impact of OFA on the incidence of atrial rhythm disturbances and / or ventricular postsurgery shock states.

    Time frame: 48 hours post-surgery

    Appearance of non-preexisting atrial fibrillation and/or of postsurgery ventricular rhythm disturbances and/or high degree cardiac conduction disorders

  4. To assess the impact of OFA on the incidence of acute post-surgery renal failure,

    Time frame: 48 hours post-surgery

    Onset of acute renal failure defined by a KDIGO score ≥ 1

  5. To assess the impact of the OFA on the incidence of post-surgery adrenal insufficiency,

    Time frame: 24 hours post-surgery

    Incidence of relative adrenal insufficiency 24 hours postoperatively by performing a synacthene test. An increase in cortisol levels <250 nmol / L within one hour of the injection of 250 µg of tetracosactide is a diagnosis

  6. Evaluate the impact of the OFA on the impact of the length of ICU and hospital stay Evaluate the impact of the OFA on the impact of the length of post-surgeryhospital stay

    Time frame: Within 2 months after surgery

    Number of days in the hospital

  7. Evaluate the impact of the OFA on the incidence of postoperative mortality

    Time frame: Within 2 months after surgery

    Number of deaths

  8. Persistence of chronic pain evaluated during a telephone call

    Time frame: 3 months after surgery

    simple numerical scale, from 0 to 10

  9. Persistence of chronic pain evaluated during a telephone call

    Time frame: 3 months after surgery

    neuropatic pain questionnaire (DN4), from 0 to 10

  10. To assess the impact of OFA on the incidence of shock

    Time frame: 48 hours post-surgery

    Presence of cardiogenic shock and vasoplegic syndrome

  11. To assess the myocardial pain

    Time frame: 48 hours post-surgery

    maximum troponin plasma level

  12. To assess the intraoperative safety

    Time frame: intraoperative periode

    Existence of bradycardia requiring atropine adminitsrtation and/or appearance of arterial hypotension or hypertension

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: OFACS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2021
Registry last updated
Mar 31, 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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