Opioid Free AnaesthesiaLISRACCNCT05136794
LIdocaine veRsus Sufentanil 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 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful… 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?
- Data collection
- How many people
- 1,772 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 15 Jan 2022
- 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 performed between January 2019 and June 2021
Who cannot join
- LVAD Heart transplantation Incomplete data in relation to outcomes
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 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.
- Conditions
- Opioid Free Anaesthesia, Opioid Anaesthesia
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anaesthesia | patient anesthtesized with lidocaine Receives: Other: Data collection | |
| Opioid anaesthesia | patients anesthetized with sufentanil Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU stays (days)
Total stay in ICU in day
Measured: Day 30
Secondary outcomes (2)
Complications
cardiac, neurological, renal, respiratory, red blood transfusion
Measured: Day 30
Hospital stays (days)
hospital stay
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Dec 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
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
- 1,772 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
- NCT05136794
- Sponsor's protocol ID
- GUINOT 2021-4
- Acronym
- LISRACC
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guinot PG, Andrei S, Durand B, Martin A, Duclos V, Spitz A, Berthoud V, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Nguyen M, Bouhemad B. Balanced Nonopioid General Anesthesia With Lidocaine Is Associated With Lower Postoperative Complications Compared With Balanced Opioid General Anesthesia With Sufentanil for Cardiac Surgery With Cardiopulmonary Bypass: A Propensity Matched Cohort Study. Anesth Analg. 2023 May 1;136(5):965-974. doi: 10.1213/ANE.0000000000006383. Epub 2023 Feb 10.
PubMed 36763521
Study at a glance
From the registry record, last updated by the sponsor on 10 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
- NCT05136794
- Acronym / sponsor ID
- LISRACC / GUINOT 2021-4
- Conditions
- Opioid Free Anaesthesia, Opioid Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,772 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 29 Nov 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.
Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid free anaesthesia | – | Other: Data collectionpatient anesthtesized with lidocaine |
| Opioid anaesthesia | – | Other: Data collectionpatients anesthetized with sufentanil |
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 (1 listed)
- age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021
Key exclusion criteria (1 listed)
- LVAD Heart transplantation Incomplete data in relation to outcomes
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 |
|---|---|---|
| Data collectioncomplications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay | Other | Opioid anaesthesia, Opioid free anaesthesia |
Primary outcome
ICU stays (days)
Time frame: Day 30
Total stay in ICU in day
2 secondary outcomes
Complications
Time frame: Day 30
Hospital stays (days)
Time frame: Day 30
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 10 Feb 2026.
- Results publication: PubMed 36763521Guinot PG, Andrei S, Durand B, Martin A, Duclos V, Spitz A, Berthoud V, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Nguyen M, Bouhemad B. Balanced Nonopioid General Anesthesia With Lidocaine Is Associated With Lower Postoperative Complications Compared With Balanced Opioid General Anesthesia With Sufentanil for Cardiac Surgery With Cardiopulmonary Bypass: A Propensity Matched Cohort Study. Anesth Analg. 2023 May 1;136(5):965-974. doi: 10.1213/ANE.0000000000006383. Epub 2023 Feb 10.
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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 1 inclusion and 1 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 10 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?
ICU stays (days) (time frame: Day 30). 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 NCT05136794, 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 10 Feb 2026.