Patients Undergoing Cardiac SurgeryPUCCARNCT03864016
Ability of Pupillometry to Reduce Sufentanil Consumption in Planned Cardiac Surgery: Randomized, Controlled, Single-center Clinical Superiority Trial
A study testing Induction and maintenance of anesthesia, Adaptation of sufentanil doses according to the usual protocol and Adjustment of sufentanil doses according to pupillometry in people with Patients Undergoing Cardiac Surgery and Patients With Coronary Artery Bypass Surgery With CEC, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The objective of general anesthesia is to obtain a loss of consciousness, stillness, and sufficient analgesia to allow surgery. Thus, general anesthesia has two components: hypnosis and analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Cardiac Surgery, Patients With Coronary Artery Bypass Surgery With CEC
- What is being tested?
- Induction and maintenance of anesthesia, Adaptation of sufentanil doses according to the usual protocol and Adjustment of sufentanil doses according to pupillometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2019to 22 Oct 2019
- Phase
- Interventional
- 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
- Person who has given written consent
- Adult patient
- Patient undergoing coronary artery bypass surgery with CEC, with or without valve surgery, by sternotomy.
- ASA <4.
Who cannot join
- Person not affiliated to the national health insurance system
- Person subject to legal protection (curatorship, guardianship)
- Person who has been deemed mentally incompetent
- Pregnant, parturient or breastfeeding woman
- Adult unable or unwilling to provide consent
- Patient with preoperative cognitive dysfunction (MMS <13) (APPENDIX 6),
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- Patient with morphine intolerance,
- Patient on long-term opioid treatment,
- Emergency surgery,
- Eye disease, corneal injury, or wearing contact lenses, a neurological disease that can influence the pupillary reflex,
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
The objective of general anesthesia is to obtain a loss of consciousness, stillness, and sufficient analgesia to allow surgery. Thus, general anesthesia has two components: hypnosis and analgesia. Combining these two components, with parallel use of a hypnotic agent and a morphine agent makes major surgery possible by limiting the stress on the body. In clinical practice, hypnosis can be assessed by a monitor of the depth of BIS®-type anesthesia, based on a simplified measurement of the patient's spontaneous cortical electroencephalographic activity. However, BIS® type monitors do not specifically judge analgesia.
Traditionally, analgesia is assessed on the basis of hemodynamic changes (blood pressure, heart rate) in relation to a nociceptive stimulus. There is an interaction between pain and cardiovascular control that is mediated by the baroreflex system. But not all hemodynamic changes during general anesthesia are necessarily secondary to nociceptive stimulation. For example, hypovolemia may be responsible for tachycardia without causing pain; opening the pericardium during cardiac surgery may increase blood pressure by increasing cardiac output.... On the other hand, a decrease in hemodynamic response can be observed in relation to the depressant effect of anesthetic agents, despite a lack of analgesia. Similarly, patients' disease-modifying treatments may mask hemodynamic responses (e.g. beta blocker). Thus, the appearance of tachycardia or high blood pressure during surgery does not necessarily reflect a nociceptive process. Currently, the available data do not allow the anaesthetist to differentiate between real hemodynamic changes related to nociception and sympathicotonia. This leads to typical management consisting of an increase in the dosage of morphine.
Pupillometry (monitoring the pupillary dilation reflex) is a simple and sensitive clinical approach that can be done during general anesthesia to specifically monitor the nociceptive component. The main objective of monitoring is to achieve a more rational use of opioids. This means optimizing opioid dosing, ensuring safety by monitoring the lowering of opioid dosages intraoperatively without the risk of waking up, and reducing postoperative hyperalgesia. In the context of cardiac surgery, the interpretation of hemodynamic changes could be facilitated by nociception monitoring coupled with anesthesia monitoring (BIS). Reducing opiod doses without changing other clinical parameters could ensure better hemodynamic stability in increasingly fragile patients.
- Conditions
- Patients Undergoing Cardiac Surgery, Patients With Coronary Artery Bypass Surgery With CEC
- Being tested
- Induction and maintenance of anesthesia, Adaptation of sufentanil doses according to the usual protocol, Adjustment of sufentanil doses according to pupillometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction and maintenance of anesthesiaDrug
The hypnotic agent used is Propofol and the morphine agent used is Sufentanil.
Adaptation of sufentanil doses according to the usual protocolDrug
At induction the target concentration of sufentanil is 0.5 ng/ml. The sufentanil dose is decided by the anaesthetist, taking into account the operating times (induction, TIO, incision, opening and sternal spacing, CEC, closure), the usual data provided by the monitoring: heart rate, blood pressure, BIS, EtCO2, modification of insufflation pressures.
Adjustment of sufentanil doses according to pupillometryDrug
At induction, the target concentration of sufentanil is 0.5 ng/ml. The dose of sufentanil is then adjusted according to the dilation reflex obtained with the PPI (Pain Pupillary Index) at predefined times.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Other | Not described Receives: Drug: Induction and maintenance of anesthesia; Drug: Adaptation of sufentanil doses according to the usual protocol |
| Pupillometry group | Experimental | Not described Receives: Drug: Induction and maintenance of anesthesia; Drug: Adjustment of sufentanil doses according to pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of sufentanil required per operation
Total dose of sufentanil expressed in µg
Measured: Through study completion an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start20 Mar 2019
- Primary completion22 Oct 2019
- Study completion22 Oct 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 Patients Undergoing Cardiac SurgeryStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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
- NCT03864016
- Sponsor's protocol ID
- BERTHOUD 2018
- Acronym
- PUCCAR
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berthoud V, Nguyen M, Appriou A, Ellouze O, Radhouani M, Constandache T, Grosjean S, Durand B, Gounot I, Bahr PA, Martin A, Nowobilski N, Bouhemad B, Guinot PG. Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study. Sci Rep. 2020 Dec 3;10(1):21056. doi: 10.1038/s41598-020-78221-5.
PubMed 33273644
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Pupillometry to Reduce Sufentanil Consumption in Planned Cardiac Surgery: Randomized, Controlled, Single-center Clinical Superiority Trial
- ClinicalTrials.gov ID
- NCT03864016
- Acronym / sponsor ID
- PUCCAR / BERTHOUD 2018
- Conditions
- Patients Undergoing Cardiac Surgery, Patients With Coronary Artery Bypass Surgery With CEC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 6 Mar 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.
The objective of general anesthesia is to obtain a loss of consciousness, stillness, and sufficient analgesia to allow surgery. Thus, general anesthesia has two components: hypnosis and analgesia. Combining these two components, with parallel use of a hypnotic agent and a morphine agent makes major surgery possible by limiting the stress on the body. In clinical practice, hypnosis can be assessed by a monitor of the depth of BIS®-type anesthesia, based on a simplified measurement of the patient's spontaneous cortical electroencephalographic activity. However, BIS® type monitors do not specifically judge analgesia.
Traditionally, analgesia is assessed on the basis of hemodynamic changes (blood pressure, heart rate) in relation to a nociceptive stimulus. There is an interaction between pain and cardiovascular control that is mediated by the baroreflex system. But not all hemodynamic changes during general anesthesia are necessarily secondary to nociceptive stimulation. For example, hypovolemia may be responsible for tachycardia without causing pain; opening the pericardium during cardiac surgery may increase blood pressure by increasing cardiac output.... On the other hand, a decrease in hemodynamic response can be observed in relation to the depressant effect of anesthetic agents, despite a lack of analgesia. Similarly, patients' disease-modifying treatments may mask hemodynamic responses (e.g. beta blocker). Thus, the appearance of tachycardia or high blood pressure during surgery does not necessarily reflect a nociceptive process. Currently, the available data do not allow the anaesthetist to differentiate between real hemodynamic changes related to nociception and sympathicotonia. This leads to typical management consisting of an increase in the dosage of morphine.
Pupillometry (monitoring the pupillary dilation reflex) is a simple and sensitive clinical approach that can be done during general anesthesia to specifically monitor the nociceptive component. The main objective of monitoring is to achieve a more rational use of opioids. This means optimizing opioid dosing, ensuring safety by monitoring the lowering of opioid dosages intraoperatively without the risk of waking up, and reducing postoperative hyperalgesia. In the context of cardiac surgery, the interpretation of hemodynamic changes could be facilitated by nociception monitoring coupled with anesthesia monitoring (BIS). Reducing opiod doses without changing other clinical parameters could ensure better hemodynamic stability in increasingly fragile patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Other | Drug: Induction and maintenance of anesthesia, Drug: Adaptation of sufentanil doses according to the usual protocol |
| Pupillometry group | Experimental | Drug: Induction and maintenance of anesthesia, Drug: Adjustment of sufentanil doses according to pupillometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Person who has given written consent
- Adult patient
- Patient undergoing coronary artery bypass surgery with CEC, with or without valve surgery, by sternotomy.
- ASA <4.
Key exclusion criteria (11 listed)
- Person not affiliated to the national health insurance system
- Person subject to legal protection (curatorship, guardianship)
- Person who has been deemed mentally incompetent
- Pregnant, parturient or breastfeeding woman
- Adult unable or unwilling to provide 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 |
|---|---|---|
| Induction and maintenance of anesthesiaThe hypnotic agent used is Propofol and the morphine agent used is Sufentanil. | Drug | Pupillometry group, Standard group |
| Adaptation of sufentanil doses according to the usual protocolAt induction the target concentration of sufentanil is 0.5 ng/ml. The sufentanil dose is decided by the anaesthetist, taking into account the operating times (induction, TIO, incision, opening and sternal spacing, CEC, closure), the usual data provided by the monitoring: heart rate, blood pressure, BIS, EtCO2, modification of insufflation pressures. | Drug | Standard group |
| Adjustment of sufentanil doses according to pupillometryAt induction, the target concentration of sufentanil is 0.5 ng/ml. The dose of sufentanil is then adjusted according to the dilation reflex obtained with the PPI (Pain Pupillary Index) at predefined times. | Drug | Pupillometry group |
Primary outcome
Total dose of sufentanil required per operation
Time frame: Through study completion an average of 2 years
Total dose of sufentanil expressed in µg
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 3 Feb 2026.
- Results publication: PubMed 33273644Berthoud V, Nguyen M, Appriou A, Ellouze O, Radhouani M, Constandache T, Grosjean S, Durand B, Gounot I, Bahr PA, Martin A, Nowobilski N, Bouhemad B, Guinot PG. Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study. Sci Rep. 2020 Dec 3;10(1):21056. doi: 10.1038/s41598-020-78221-5.
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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 study testing Induction and maintenance of anesthesia, Adaptation of sufentanil doses according to the usual protocol and Adjustment of sufentanil doses according to pupillometry in people with Patients Undergoing Cardiac Surgery and Patients With Coronary Artery Bypass Surgery With CEC, 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 4 inclusion and 11 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 3 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?
Total dose of sufentanil required per operation (time frame: Through study completion an average of 2 years). 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 NCT03864016, 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 3 Feb 2026.