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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group NOL | Experimental | Morphinomimetics will be administered according to NOL Index values. |
|
| Group control | No Intervention | Morphinomimetics will be administered according to the usual criteria. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nol index | Procedure | Morphinomimetics will be administered according to NOL Index values or according to the usual criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus. |
| From enrollment to within 48 hours post-extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of intraoperative morphinomimetics | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabien ESPITALIER, PU-PH | Contact | +33 2 47 47 17 47 | fabien.espitalier@univ-tours.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | France |
|
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Randomized controlled trial
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| 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 | 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. | 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. | From extubation to 48 hours postoperative |
| Number of episodes of pain | Numerical scale > 3 | From extubation to 48 hours postoperative. |
| 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 | Time from hospital admission to hospital discharge | 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. | 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. | 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% | 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 | From enrollment to 48 hours post-extubation |
| Occurrence of ileus | Occurrence of ileus: absence of gas or stool. | From enrollment to 48 hours post-extubation |
| CH BLOIS | Blois | France |
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| Chu Brest | Brest | France |
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| Chu Nantes | Nantes | France |
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| Chru Tours Sar1 | Tours | France |
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| Chru Tours Sar2 | Tours | France |
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