Opioid-free AnesthesiaPhase 3OFACARNCT04886453
Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
A Phase 3 study testing Balanced general anesthesia without morphine, Standard general anesthesia balanced with morphine and Data collection in people with Opioid-free Anesthesia and Cardiac Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-free Anesthesia, Cardiac Surgery
- What is being tested?
- Balanced general anesthesia without morphine, Standard general anesthesia balanced with morphine and Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2021to 21 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has provided written and informed consent
- Adult patient
- Patient undergoing cardiac surgery which is:
- Scheduled
- With bypass surgery
- Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Opioid-free Anesthesia, Cardiac Surgery
- Being tested
- Balanced general anesthesia without morphine, Standard general anesthesia balanced with morphine, Data collection, Assessment of pain, Recovery quality score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced general anesthesia without morphineDrug
Balanced general anesthesia without morphine
Standard general anesthesia balanced with morphineDrug
Standard general anesthesia balanced with morphine
Data collectionOther
Data collection
Assessment of painOther
visual analog scale
Recovery quality scoreOther
QoR15 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Drug: Balanced general anesthesia without morphine; Other: Data collection; Other: Assessment of pain; Other: Recovery quality score |
| Controle | Active comparator | Not described Receives: Drug: Standard general anesthesia balanced with morphine; Other: Data collection; Other: Assessment of pain; Other: Recovery quality score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least one postoperative complication
Post-operative complications:
- postoperative neurological dysfunction
- acute renal failure
- acute respiratory failure
- cardiovascular complications
- death
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start30 Aug 2021
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886453
- Sponsor's protocol ID
- BOUHEMAD PHRCI 2019
- Acronym
- OFACAR
- Status last verified
- May 2024
- First submitted
- 10 May 2021
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
- ClinicalTrials.gov ID
- NCT04886453
- Acronym / sponsor ID
- OFACAR / BOUHEMAD PHRCI 2019
- Conditions
- Opioid-free Anesthesia, Cardiac Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Balanced general anesthesia without morphine, Other: Data collection, Other: Assessment of pain, Other: Recovery quality score |
| Controle | Active comparator | Drug: Standard general anesthesia balanced with morphine, Other: Data collection, Other: Assessment of pain, Other: Recovery quality score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who has provided written and informed consent
- Adult patient
- Patient undergoing cardiac surgery which is:
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced general anesthesia without morphineBalanced general anesthesia without morphine | Drug | Intervention |
| Standard general anesthesia balanced with morphineStandard general anesthesia balanced with morphine | Drug | Controle |
| Data collectionData collection | Other | Controle, Intervention |
| Assessment of painvisual analog scale | Other | Controle, Intervention |
| Recovery quality scoreQoR15 questionnaire | Other | Controle, Intervention |
Primary outcome
Occurrence of at least one postoperative complication
Time frame: 30 days post-surgery
Post-operative complications: * postoperative neurological dysfunction * acute renal failure * acute respiratory failure * cardiovascular complications * death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Balanced general anesthesia without morphine, Standard general anesthesia balanced with morphine and Data collection in people with Opioid-free Anesthesia and Cardiac Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at least one postoperative complication (time frame: 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.