AnesthesiaNOL-ImpactNCT06861634
Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics
A study testing Nol index in people with Anesthesia and Intensive Care Medicine, run by University Hospital, Tours at 6 sites in France.
Trial summary
Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects. However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Intensive Care Medicine
- What is being tested?
- Nol index
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female
- Subject aged ≥ 18 years
- Affiliated with a social security scheme
- Having given written informed consent to participate study
- Admitted for major surgery expected to last more than 2 hours
- Under general anesthesia with tracheal intubation
- For a planned hospital stay of at least 48 hours
- Participant's ability to understand the nature and objectives of the study to comply with study requirements.
Who cannot join
- Contraindication to one of the drugs used for anesthesia
- Urgent surgery
- Intracranial surgery
- Transplant surgery
- Cardiac surgery
- Surgery with scheduled local anesthesia
Show all 20Show fewer
- Patient requiring postoperative intubation
- Neuromuscular disease
- Patient chronically using morphinomimetics
- Chronic pain patient
- Patients with a history of sleep apnea
- Conditions likely to interfere with photoplethysmograph signal acquisition or skin conductance (excessive or tremors of the extremities, skin lesions or burns)
- Patients wearing false nails and/or nail polish
- Contraindication to the use of the PMD 200 ™ medical device (including cardiovascular resuscitation and cardioversion/defibrillation);
- Patient with an implanted pacemaker or defibrillator
- Treatment with β-blockers
- Preoperative cardiac arrhythmia
- Pregnant or breast-feeding women. A β-HCG test will be systematically performed prior to inclusion of non-menopausal women menopausal women
- Patients under legal protection (safeguard of justice, curatorship guardianship) or deprived of liberty
- Participation in other interventional research involving an experimental drug or medical device.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
Chu Angers
Angers
Sigismond LASOCKI, PH, +33 6 03 16 62 95, SiLasocki@chu-angers.fr
CH BLOIS
Blois
Thibault CAMOZZI, PH, +33 2 54 55 66 37, thibaultcamozzi@hotmail.com
Chu Brest
Brest
Anaïs CAILLARD, PH, +33 2 98 22 33 33, anais.caillard@chu-brest.fr
Chu Nantes
Nantes
Raphaël CINOTTI, PU-PH, +33 2 40 08 47 31, Raphael.CINOTTI@chu-nantes.fr
Chru Tours Sar1
Tours
Marc LAFFON, PU-PH, +33 2 47 47 38 10, marc.laffon@univ-tours.fr
Chru Tours Sar2
Tours
Fabien ESPITALIER, PU-PH, +33 2 47 47 17 47, fabien.espitalier@univ-tours.fr
About this study
Official title: Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics: A Randomized Controlled Trial
Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects.
However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics.
The Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?
- Conditions
- Anesthesia, Intensive Care Medicine
- Being tested
- Nol index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nol indexProcedure or surgery
Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.
| Study group | Role | What they receive |
|---|---|---|
| Group NOL | Experimental | Morphinomimetics will be administered according to NOL Index values. Receives: Procedure: Nol index |
| Group control | No intervention | Morphinomimetics will be administered according to the usual criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.
- occurrence of hypoxemia: at least 1 episode of SpO2 < 95%,
- occurrence of nausea-vomiting: at least one episode of nausea requiring antiemetic treatment, or at least one episode of vomiting,
- occurrence of ileus: absence of gas or stool.
Measured: From enrollment to within 48 hours post-extubation.
Secondary outcomes (14)
Total consumption of intraoperative morphinomimetics
Measured: From intervention to 48 hours after extubation
Total consumption of intraoperative vasoconstrictors
type of vasoconstrictor, amount of vasaoconstrictor used and number of boli of vasoconstrictor will be considered
Measured: From induction to extubation, up to 8 hours
Time of extubation
Delay between the end of the hypnotic infusion and the patient becoming conscious and able to breathe freely
Measured: From the end of anesthesia administration to extubation, up to 1 hours
Time from extubation to theoretical post-anesthesia care unit discharge time with Aldrete score at 10
Aldrete's score will be assessed every 5 minutes during his stay in the post-anesthesia care unit. Discharge from the post-anesthesia care unit will be possible when the Aldrete score reaches 10.
Measured: From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours
Maximum intensity of pain
Numeric rating scale (NRS): Patients rate their pain intensity on a 11-point Numeric Rating Scale (NRS-11), where 0 indicates the absence of pain and 10 means the worst possible pain.
Measured: From extubation to 48 hours postoperative
Number of episodes of pain
Numerical scale > 3
Measured: From extubation to 48 hours postoperative.
Number of episodes of hypoxemia
Measured: From intervention to 48 hours post-extubation
Number of episodes of nausea and vomiting
Measured: From intervention to 48 hours post-extubation
Hospital stay length
Time from hospital admission to hospital discharge
Measured: From admission to hospital discharge up to 1 month.
Quality of post-operative recovery
The French version of the Quality of Recovery -15 (FQoR-15) is is a validated multidimensional PROM-based questionnaire that measures postoperative quality of recovery. The QoR-15 scale consists of 15 questions, where the patient is asked to quote dimensions of his/her recovery from 0 to 10. After summing all 15 responses, the QoR-15 is presented as a score, ranging from 0 to 150, with 150 corresponding to an ideal health status.
Measured: From enrollment to 24 hours and 48 hours after chirurgical intervention
Intensity of chronic pain
Phone contact : DN4 form The DN4 form (douleur neuropathique - neuropathic pain 4) is a form with 10 questions. The results are from 0 to 10. A result greater than 4 is considered positive.
Measured: At 3 months, at 6 months and at 12 months (end of the study)
Occurrence of hypoxemia
Occurrence of hypoxemia: at least 1 episode of SpO2 < 95%
Measured: From enrollment to 48 hours post-extubation
Occurrence of nausea-vomiting
Occurrence of nausea-vomiting: at least one episode of nausea requiring antiemetictreatment, or at least one episode of vomiting
Measured: From enrollment to 48 hours post-extubation
Occurrence of ileus
Occurrence of ileus: absence of gas or stool.
Measured: From enrollment to 48 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861634
- Sponsor's protocol ID
- DR220248
- Acronym
- NOL-Impact
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06861634
- Acronym / sponsor ID
- NOL-Impact / DR220248
- Conditions
- Anesthesia, Intensive Care Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 Mar 2025 (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.
Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects.
However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics.
The Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group NOL | Experimental | Procedure: Nol indexMorphinomimetics will be administered according to NOL Index values. |
| Group control | No intervention | –Morphinomimetics will be administered according to the usual criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female
- Subject aged ≥ 18 years
- Affiliated with a social security scheme
- Having given written informed consent to participate study
- Admitted for major surgery expected to last more than 2 hours
Key exclusion criteria (20 listed)
- Contraindication to one of the drugs used for anesthesia
- Urgent surgery
- Intracranial surgery
- Transplant surgery
- Cardiac surgery
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 |
|---|---|---|
| Nol indexMorphinomimetics will be administered according to NOL Index values or according to the usual criteria. | Procedure or surgery | Group NOL |
Primary outcome
Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.
Time frame: From enrollment to within 48 hours post-extubation.
1. occurrence of hypoxemia: at least 1 episode of SpO2 < 95%, 2. occurrence of nausea-vomiting: at least one episode of nausea requiring antiemetic treatment, or at least one episode of vomiting, 3. occurrence of ileus: absence of gas or stool.
14 secondary outcomes
Total consumption of intraoperative morphinomimetics
Time frame: From intervention to 48 hours after extubation
Total consumption of intraoperative vasoconstrictors
Time frame: From induction to extubation, up to 8 hours
Time of extubation
Time frame: From the end of anesthesia administration to extubation, up to 1 hours
Time from extubation to theoretical post-anesthesia care unit discharge time with Aldrete score at 10
Time frame: From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours
Maximum intensity of pain
Time frame: From extubation to 48 hours postoperative
Number of episodes of pain
Time frame: From extubation to 48 hours postoperative.
Number of episodes of hypoxemia
Time frame: From intervention to 48 hours post-extubation
Number of episodes of nausea and vomiting
Time frame: From intervention to 48 hours post-extubation
Hospital stay length
Time frame: From admission to hospital discharge up to 1 month.
Quality of post-operative recovery
Time frame: From enrollment to 24 hours and 48 hours after chirurgical intervention
Intensity of chronic pain
Time frame: At 3 months, at 6 months and at 12 months (end of the study)
Occurrence of hypoxemia
Time frame: From enrollment to 48 hours post-extubation
Occurrence of nausea-vomiting
Time frame: From enrollment to 48 hours post-extubation
Occurrence of ileus
Time frame: From enrollment to 48 hours post-extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nol index in people with Anesthesia and Intensive Care Medicine, run by University Hospital, Tours at 6 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 8 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: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabien ESPITALIER, PU-PH (+33 2 47 47 17 47, fabien.espitalier@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus. (time frame: From enrollment to within 48 hours post-extubation.). 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 6 Mar 2025.