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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female

Subject aged ≥ 18 years

Affiliated with a social security scheme

Having given written informed consent to participate study

Disqualifiers

Contraindication to one of the drugs used for anesthesia

Urgent surgery

Intracranial surgery

Transplant surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nol index

    Procedure/Surgery

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

Treatment groups

332 Participants
are divided into 2 treatment groups
Group A: Group NOLExperimental treatment 1 intervention
Group B: Group controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

Total consumption of intraoperative morphinomimetics

Time frame
From intervention to 48 hours after extubation
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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