Opioid Free AnaesthesiaOFACAR 1NCT03816592
Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
An observational study of Opioid Free Anaesthesia and Opioid Anaesthesia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Free Anaesthesia, Opioid Anaesthesia
- What is being tested?
- Opioid free anaesthesia and Opioid anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 31 Mar 2019
- Phase
- Observational
- 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
Study population: Cardiac surgical
Who may be able to join
- age over 18 years
- cardiac surgery with cardiopulmonary bypass
Who cannot join
- patient with chronic analgesia treatment
- patient on antidepressive therapy
- gabapentin use
- preoperative cognitive dysfunction
- patient treated with zyvoxid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
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).
- Conditions
- Opioid Free Anaesthesia, Opioid Anaesthesia
- Being tested
- Opioid free anaesthesia, Opioid anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid free anaesthesiaProcedure or surgery
patient anesthtesized with lidocaine, ketamine and dexamethasone
Opioid anaesthesiaProcedure or surgery
patients anesthetized with sufentanil ketamine and dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anaesthesia | patient anesthtesized with lidocaine, ketamine and dexamethasone Receives: Procedure: Opioid free anaesthesia | |
| Opioid anaesthesia | patients anesthetized with sufentanil ketamine and dexamethasone Receives: Procedure: Opioid anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total morphine consumption over the first 48 post operative hours in milligrammes
Measured: Day 2
Complications
composite end point of post operative complications (cardiac, neurological, renal, respiratory)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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 Opioid Free AnaesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 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
- NCT03816592
- Sponsor's protocol ID
- GUINOT 2019
- Acronym
- OFACAR 1
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2019
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.
PubMed 31366330
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
- ClinicalTrials.gov ID
- NCT03816592
- Acronym / sponsor ID
- OFACAR 1 / GUINOT 2019
- Conditions
- Opioid Free Anaesthesia, Opioid Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 25 Jan 2019 (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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid free anaesthesia | – | Procedure: Opioid free anaesthesiapatient anesthtesized with lidocaine, ketamine and dexamethasone |
| Opioid anaesthesia | – | Procedure: Opioid anaesthesiapatients anesthetized with sufentanil ketamine and dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgical
Key inclusion criteria (2 listed)
- age over 18 years
- cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (5 listed)
- patient with chronic analgesia treatment
- patient on antidepressive therapy
- gabapentin use
- preoperative cognitive dysfunction
- patient treated with zyvoxid
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 |
|---|---|---|
| Opioid free anaesthesiapatient anesthtesized with lidocaine, ketamine and dexamethasone | Procedure or surgery | Opioid free anaesthesia |
| Opioid anaesthesiapatients anesthetized with sufentanil ketamine and dexamethasone | Procedure or surgery | Opioid anaesthesia |
Primary outcome
Morphine consumption
Time frame: Day 2
Total morphine consumption over the first 48 post operative hours in milligrammes
Complications
Time frame: Day 7
composite end point of post operative complications (cardiac, neurological, renal, respiratory)
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 4 Feb 2026.
- Results publication: PubMed 31366330Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.
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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?
An observational study of Opioid Free Anaesthesia and Opioid Anaesthesia, 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 2 inclusion and 5 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 4 Feb 2026. 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.
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?
Morphine consumption (time frame: Day 2). The study lists 2 primary outcomes in all. 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 NCT03816592, 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 4 Feb 2026.