Nol index
ProcedureMorphinomimetics will be administered according to NOL Index values or according to the usual criteria.
NCT Number: NCT06861634
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?
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Chu Angers, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.
Time frame: From enrollment to within 48 hours post-extubation.
Time frame: From intervention to 48 hours after extubation
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
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
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.
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.
Time frame: From extubation to 48 hours postoperative.
Numerical scale > 3
Time frame: From intervention to 48 hours post-extubation
Time frame: From intervention to 48 hours post-extubation
Time frame: From admission to hospital discharge up to 1 month.
Time from hospital admission to hospital discharge
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.
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.
Time frame: From enrollment to 48 hours post-extubation
Occurrence of hypoxemia: at least 1 episode of SpO2 < 95%
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
Time frame: From enrollment to 48 hours post-extubation
Occurrence of ileus: absence of gas or stool.
Contact information is provided by the study sponsor or research team.
University Hospital, Tours
Other
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
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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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