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CompletedNCT04886453OFACARUpdated May 17, 2024

Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

A Phase 3 interventional study of Balanced general anesthesia without morphine and Standard general anesthesia balanced with morphine in Opioid-free Anesthesia and Cardiac Surgery, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Centre Hospitalier Universitaire Dijon · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:

  • better analgesia and decreased postoperative morphine consumption,
  • better respiratory function,
  • better hemodynamic stability,
  • better postoperative cognitive function.

The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:

  • Improved intraoperative hemodynamic stability
  • A decrease in the incidence of postoperative complications
  • A reduction in intensive care and hospital length of stay
02

Conditions studied

  • Opioid-free Anesthesia
  • Cardiac Surgery
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient who has provided written and informed consent
  • Adult patient

  • Patient undergoing cardiac surgery which is:

    1. Scheduled
    2. With bypass surgery
    3. Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery

Exclusion criteria

Exclusion Criteria:

  • Person not affiliated to national health insurance
  • Person under legal protection (curatorship, guardianship)
  • Person under court order
  • Pregnant or breastfeeding woman
  • Adult unable to express consent
  • Patient already included once in the study
  • Patient requiring emergency surgery within 24 hours
  • Patients with hypersensitivity to local anesthetics or opiates or to any of the excipients in the products used
  • Patients on antidepressants, neuroleptics such as non-selective MAOIs (iproniazid), selective A MAOI (moclobemide), selective B MAOI (selegiline) gabapentin (Neurontin®)
  • Patients with an unprotected atrioventricular conduction disorder
  • Patients with a prolonged QTc (> 450 ms) on preoperative ECG
  • Patient with severe liver failure (PT\< 30%)
  • Patient suffering from respiratory failure (Long-term oxygen therapy patient except OSA)
  • Patient with uncontrolled epilepsy
  • Patient with preoperative cognitive dysfunction (MMS \<24)
  • Patient with intracranial hypertension
  • Patient with chronic kidney failure (dialysis, creatinine > 200 μmol L-1)
  • Patient with porphyria
  • Patients treated with linezolid (Zyvoxid®)
  • Patients with severe arterial hypotension (systolic BP\<90 mmHg)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
321 participants (actual)

Study arms

  • Experimental
    Intervention

    Drug: Balanced general anesthesia without morphine · Other: Data collection · Other: Assessment of pain · Other: Recovery quality score

  • Active comparator
    Controle

    Drug: Standard general anesthesia balanced with morphine · Other: Data collection · Other: Assessment of pain · Other: Recovery quality score

Interventions

  • DrugBalanced general anesthesia without morphine

    Balanced general anesthesia without morphine

  • DrugStandard general anesthesia balanced with morphine

    Standard general anesthesia balanced with morphine

  • OtherData collection

    Data collection

  • OtherAssessment of pain

    visual analog scale

  • OtherRecovery quality score

    QoR15 questionnaire

06

What researchers measure

Primary outcomes

  1. Occurrence of at least one postoperative complication

    Post-operative complications: * postoperative neurological dysfunction * acute renal failure * acute respiratory failure * cardiovascular complications * death

    Time frame: 30 days post-surgery

07

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, 21000, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2021 to primary completion in Mar 2024, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2021
First posted
May 14, 2021
StartActual
Aug 30, 2021
Primary completionActual
Mar 21, 2024
CompletionActual
Mar 21, 2024
Last update
May 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04886453
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
May 14, 2021
Start date
Aug 30, 2021
Primary completion
Mar 21, 2024
Completion
Mar 21, 2024
Last update
May 17, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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