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

Not Applicable

Not yet recruiting

• Conditions: Anesthesia; Intensive Care Medicine

• Registration Number: NCT06861634
• Lead Sponsor: University Hospital, Tours

Brief 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. 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 332

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.	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.

Secondary Outcome Measures

Name	Time	Method
Total consumption of intraoperative morphinomimetics	From intervention to 48 hours after extubation
Total consumption of intraoperative vasoconstrictors	From induction to extubation, up to 8 hours	type of vasoconstrictor, amount of vasaoconstrictor used and number of boli of vasoconstrictor will be considered
Time of extubation	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
Time from extubation to theoretical post-anesthesia care unit discharge time with Aldrete score at 10	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.
Maximum intensity of pain	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.
Number of episodes of pain	From extubation to 48 hours postoperative.	Numerical scale \> 3
Number of episodes of hypoxemia	From intervention to 48 hours post-extubation
Number of episodes of nausea and vomiting	From intervention to 48 hours post-extubation
Hospital stay length	From admission to hospital discharge up to 1 month.	Time from hospital admission to hospital discharge
Quality of post-operative recovery	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.
Intensity of chronic pain	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.
Occurrence of hypoxemia	From enrollment to 48 hours post-extubation	Occurrence of hypoxemia: at least 1 episode of SpO2 \< 95%
Occurrence of nausea-vomiting	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
Occurrence of ileus	From enrollment to 48 hours post-extubation	Occurrence of ileus: absence of gas or stool.

Trial Locations

Locations (6)

Chu Angers; 🇫🇷 Angers, France

CH BLOIS; 🇫🇷 Blois, France

Chu Brest; 🇫🇷 Brest, France

Chu Nantes; 🇫🇷 Nantes, France

Chru Tours Sar1; 🇫🇷 Tours, France

Chru Tours Sar2; 🇫🇷 Tours, France