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NCT Number: NCT06861634

Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Contraindication to one of the drugs used for anesthesia
  • Urgent surgery
  • Intracranial surgery
  • Transplant surgery
  • Cardiac surgery
  • Surgery with scheduled local anesthesia
  • 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.

Treatment and study plan

Nol index

Procedure

Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.

Primary outcomes

  1. 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.

    • 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.

Secondary outcomes

  1. Total consumption of intraoperative morphinomimetics

    Time frame: From intervention to 48 hours after extubation

  2. Total consumption of intraoperative vasoconstrictors

    Time frame: From induction to extubation, up to 8 hours

    type of vasoconstrictor, amount of vasaoconstrictor used and number of boli of vasoconstrictor will be considered

  3. Time of extubation

    Time frame: From the end of anesthesia administration to extubation, up to 1 hours

    Delay between the end of the hypnotic infusion and the patient becoming conscious and able to breathe freely

  4. 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

    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.

  5. Maximum intensity of pain

    Time frame: From extubation to 48 hours postoperative

    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.

  6. Number of episodes of pain

    Time frame: From extubation to 48 hours postoperative.

    Numerical scale > 3

  7. Number of episodes of hypoxemia

    Time frame: From intervention to 48 hours post-extubation

  8. Number of episodes of nausea and vomiting

    Time frame: From intervention to 48 hours post-extubation

  9. Hospital stay length

    Time frame: From admission to hospital discharge up to 1 month.

    Time from hospital admission to hospital discharge

  10. Quality of post-operative recovery

    Time frame: From enrollment to 24 hours and 48 hours after chirurgical intervention

    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.

  11. Intensity of chronic pain

    Time frame: At 3 months, at 6 months and at 12 months (end of the study)

    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.

  12. Occurrence of hypoxemia

    Time frame: From enrollment to 48 hours post-extubation

    Occurrence of hypoxemia: at least 1 episode of SpO2 < 95%

  13. Occurrence of nausea-vomiting

    Time frame: From enrollment to 48 hours post-extubation

    Occurrence of nausea-vomiting: at least one episode of nausea requiring antiemetictreatment, or at least one episode of vomiting

  14. Occurrence of ileus

    Time frame: From enrollment to 48 hours post-extubation

    Occurrence of ileus: absence of gas or stool.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabien ESPITALIER, PU-PH

CONTACT

[email protected]

+33 2 47 47 17 47

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: NOL-Impact

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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