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

N/ANot Yet RecruitingNCT06861634

University Hospital, Tours332 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

332

Conditions

Anesthesia Intensive Care Medicine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: From enrollment to within 48 hours post-extubation.

Secondary Outcomes

Total consumption of intraoperative morphinomimetics

Time frame: 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

Time frame: 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

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

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.

Time frame: 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.

Time frame: From extubation to 48 hours postoperative

Number of episodes of pain

Numerical scale \> 3

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 from hospital admission to hospital discharge

Time frame: 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.

Time frame: 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.

Time frame: 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%

Time frame: 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

Time frame: From enrollment to 48 hours post-extubation

Occurrence of ileus

Occurrence of ileus: absence of gas or stool.

Time frame: From enrollment to 48 hours post-extubation

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts