AnesthesiaPhase 3OFACSNCT04940689
Opioid-Free Anesthesia in Cardiac Surgery
A Phase 3 study testing Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg and Remifentanil in people with Anesthesia, run by University Hospital, Rouen at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 5 sitesFrance
- Study dates
- 22 Jul 2021to 28 Aug 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Amiens Univesrity Hospital
Amiens
CAEN university Hospital
Caen
Lille Hopistal University
Lille
Montpellier University Hospital
Montpellier
Rouen University Hospital
Rouen, France, Normandy, 76031
About this study
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.
Read the detailed description
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.
- Conditions
- Anesthesia
- Being tested
- Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kgDrug
Also called experimental
The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin.
RemifentanilDrug
Also called Control
The patient will be anesthetized with morphin.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | Active comparator | General anesthesia strategy with morphine:
* Within 10 minutes before the induction of general anesthesia: administration of a placebo of 50 mL of 0.9% NaCl by slow IV
* The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with IV curare and remifentanil (morphine derivative) IV for a concentration target of 4 ng / mL.
* Maintenance of anesthesia will be carried out with propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qs bispectral index 40-60) and remifentanil (target concentration 1-10 ng / mL). The administration of curare will be carried out as needed. In order to anticipate the sudden end of the analgesia, an administration of morphine 0.15 mg / kg IV will be carried out 30 minutes before the end of the intervention as recommended Receives: Drug: Remifentanil |
| OFA arm | Experimental | General anesthesia strategy without morphine
* Within 10 minutes before the induction of general anesthesia: pre-induction dose of dexmedetomidine 0.5 g / kg and lidocaine 1.5 mg / kg by slow IV.
* The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with an IV curare
* The maintenance of the anesthesia will be carried out by propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qsp bispectral index 40-60), dexmedetomidine 0.5-1.0 g / kg / h, lidocaine 2 mg / kg / h. The administration of curare will be carried out as needed. Receives: Drug: Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 48 hours post-surgery
Secondary outcomes (12)
To assess the impact of OFA on the incidence of postoperative nausea and vomiting.
Existence of post-surgery nausea
Measured: 48 hours post-surgery
To assess the impact of OFA on the incidence of postsurgery pain.
Number of post-surgery pain episodes at rest (VAS ≥ 3) and total morphine consumption
Measured: 48 hours post-surgery
To assess the impact of OFA on the incidence of atrial rhythm disturbances and / or ventricular postsurgery shock states.
Appearance of non-preexisting atrial fibrillation and/or of postsurgery ventricular rhythm disturbances and/or high degree cardiac conduction disorders
Measured: 48 hours post-surgery
To assess the impact of OFA on the incidence of acute post-surgery renal failure,
Onset of acute renal failure defined by a KDIGO score ≥ 1
Measured: 48 hours post-surgery
To assess the impact of the OFA on the incidence of post-surgery adrenal insufficiency,
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
Measured: 24 hours post-surgery
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
Number of days in the hospital
Measured: Within 2 months after surgery
Evaluate the impact of the OFA on the incidence of postoperative mortality
Number of deaths
Measured: Within 2 months after surgery
Persistence of chronic pain evaluated during a telephone call
simple numerical scale, from 0 to 10
Measured: 3 months after surgery
Persistence of chronic pain evaluated during a telephone call
neuropatic pain questionnaire (DN4), from 0 to 10
Measured: 3 months after surgery
To assess the impact of OFA on the incidence of shock
Presence of cardiogenic shock and vasoplegic syndrome
Measured: 48 hours post-surgery
To assess the myocardial pain
maximum troponin plasma level
Measured: 48 hours post-surgery
To assess the intraoperative safety
Existence of bradycardia requiring atropine adminitsrtation and/or appearance of arterial hypotension or hypertension
Measured: intraoperative periode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start22 Jul 2021
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940689
- Sponsor's protocol ID
- 2019/0399/HP
- Other IDs
- 2020-002126-90
- Acronym
- OFACS
- Status last verified
- May 2025
- First submitted
- 7 May 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated by this trial will not be publicly available but upon reasonable request to the corresponding author (Emmanuel Besnier, emmanuel.besnier@chu-rouen.fr). In this case, data will be totally deidentified. Requesters should provide a structured and detailed protocol for the proposed study and the reasons for reusing data.
Publications
Besnier E, Moussa MD, Thill C, Vallin F, Donnadieu N, Ruault S, Lorne E, Scherrer V, Lanoiselee J, Lefebvre T, Sentenac P, Abou-Arab O. Opioid-free anaesthesia with dexmedetomidine and lidocaine versus remifentanil-based anaesthesia in cardiac surgery: study protocol of a French randomised, multicentre and single-blinded OFACS trial. BMJ Open. 2024 Jun 3;14(6):e079984. doi: 10.1136/bmjopen-2023-079984.
PubMed 38830745
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Anesthesia in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04940689
- Acronym / sponsor ID
- OFACS / 2019/0399/HP
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 25 Jun 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | Active comparator | Drug: RemifentanilGeneral anesthesia strategy with morphine: * Within 10 minutes before the induction of general anesthesia: administration of a placebo of 50 mL of 0.9% NaCl by slow IV * The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with IV curare and remifentanil (morphine derivative) IV for a concentration target of 4 ng / mL. * Maintenance of anesthesia will be carried out with propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qs bispectral index 40-60) and remifentanil (target concentration 1-10 ng / mL). The administration of curare will be carried out as needed. In order to anticipate the sudden end of the analgesia, an administration of morphine 0.15 mg / kg IV will be carried out 30 minutes before the end of the intervention as recommended |
| OFA arm | Experimental | Drug: Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kgGeneral anesthesia strategy without morphine * Within 10 minutes before the induction of general anesthesia: pre-induction dose of dexmedetomidine 0.5 g / kg and lidocaine 1.5 mg / kg by slow IV. * The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with an IV curare * The maintenance of the anesthesia will be carried out by propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qsp bispectral index 40-60), dexmedetomidine 0.5-1.0 g / kg / h, lidocaine 2 mg / kg / h. The administration of curare will be carried out as needed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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%
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 |
|---|---|---|
| Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kgAlso: experimentalThe patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin. | Drug | OFA arm |
| RemifentanilAlso: ControlThe patient will be anesthetized with morphin. | Drug | Standard arm |
Primary outcome
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
12 secondary outcomes
To assess the impact of OFA on the incidence of postoperative nausea and vomiting.
Time frame: 48 hours post-surgery
To assess the impact of OFA on the incidence of postsurgery pain.
Time frame: 48 hours post-surgery
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
To assess the impact of OFA on the incidence of acute post-surgery renal failure,
Time frame: 48 hours post-surgery
To assess the impact of the OFA on the incidence of post-surgery adrenal insufficiency,
Time frame: 24 hours post-surgery
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
Evaluate the impact of the OFA on the incidence of postoperative mortality
Time frame: Within 2 months after surgery
Persistence of chronic pain evaluated during a telephone call
Time frame: 3 months after surgery
Persistence of chronic pain evaluated during a telephone call
Time frame: 3 months after surgery
To assess the impact of OFA on the incidence of shock
Time frame: 48 hours post-surgery
To assess the myocardial pain
Time frame: 48 hours post-surgery
To assess the intraoperative safety
Time frame: intraoperative periode
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 31 Mar 2026.
- Derived from this study: PubMed 38830745Besnier E, Moussa MD, Thill C, Vallin F, Donnadieu N, Ruault S, Lorne E, Scherrer V, Lanoiselee J, Lefebvre T, Sentenac P, Abou-Arab O. Opioid-free anaesthesia with dexmedetomidine and lidocaine versus remifentanil-based anaesthesia in cardiac surgery: study protocol of a French randomised, multicentre and single-blinded OFACS trial. BMJ Open. 2024 Jun 3;14(6):e079984. doi: 10.1136/bmjopen-2023-079984.
- Individual participant dataSharing planned: Yes. Data generated by this trial will not be publicly available but upon reasonable request to the corresponding author (Emmanuel Besnier, emmanuel.besnier@chu-rouen.fr). In this case, data will be totally deidentified. Requesters should provide a structured and detailed protocol for the proposed study and the reasons for reusing data.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg and Remifentanil in people with Anesthesia, run by University Hospital, Rouen at 5 sites 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 4 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940689, which also lists 1 linked publication.
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 31 Mar 2026.