Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03618082 Statut inconnu

Titre

Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study (GOALDAN)

Type

Interventional

Pathologie

Douleur postopératoire

Phase

Phase 3

Promoteur

University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)

Date de début

juin 2019

Date de fin

août 2022

Dernière mise à jour

29 juin 2024

Résumé

The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain. The investigators hypothesized that a prophylactic administration of morphine in patients with risk of postoperative pain determined by the ANI at the end of the intervention would reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI and minimal alveolar concentration (MAC) of desflurane could improve the perioperative hemodynamic, and the postoperative becoming.

Détail

Voir le détail Visits: - The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator - will preselect potentially eligible patients - will offer to participate to this study - will give the notice form to the patients - will present the research: objectives, benefits and constraints for the patients - will check that patients understand the verbally administered Numeric Rating Scale (NRS) for the assessment of the postoperative This verbally administered NRS is routinely presented to all patients at a surgical intervention. - The intervention day (D0): The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria. The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF. • Surgical intervention (D0): All patients will receive a usual multimodal analgesia associating level 1 analgesics (acetaminophen, ketoprofen, nefopam) or level 2 (tramadol) administered 30 to 60 min before the foreseeable end of the surgical intervention. All patients will receive 0.1 to 0.2 mg/kg of morphine within the 30 min preceding the end of the surgical intervention according to the usual practice. Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room. If the verbally NRS > 3, a morphine titration by IV administration of 2 to 3 mg of morphine will be realised then the verbally NRS will be collected 5 min after, according to the usual practice. This morphine titration will continued until the obtaining of a verbal NRS ≤ 3. As an alternative to this morphine titration, where possible, a peripheral nerve block may be proposed to the patient and performed by the investigator to relieve the patient. If the patient is transferred directly in ICU without being extubated at the end of the intervention and so without transiting by the recovery room, the patient will be excluded from the study. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - Auvergne - France	Lise LACLAUTRE	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 18≤ Age <65 years old

- Patient operated on a scheduled surgery under general anesthesia

- Patient with a American Society of Anesthesiologists (ASA) score of I to III

- Patient having given his consent in the manner described in Article L1122-1-1 of the
Public Health Code

- Patient affiliated with a social security regimen or beneficiary of such a regimen

Critère de non inclusion

- general anesthesia without extubating (laryngeal mask)

- neuraxial preoperative regional anesthesia (epidural or rachianalgesia)

- opioid-free anesthesia

- preoperative peripheral nerve block with analgesic aim (infiltration of a local
surgical anesthetic or transversus abdominis plane block-TAP block-authorized)

- arrhythmia or the presence of a pacemaker

- ambulatory surgery

- cardiac or cerebral surgery

- obstetrical surgery (caesarean)

- surgery performed with neuraxial regional anesthesia or peripheral anesthesia alone

- surgery performed in prone position

- urgent surgery

- endoscopic procedure or interventional radiology

- chronic pain treated with opiates

- expected surgery duration < 1h

- pathology of the autonomic nervous system (epilepsy, history of transient attack or
stroke, paraplegia, hemiplegia, orthostatic hypotension, autonomic dysfunction)

- Patient with cardiogenic or septic shock

- Continuous infusion of vasoactive agents (ephedrine, phenylephrine, adrenaline, or
noradrenaline)

- Postoperative transfer planned in intensive care unit (intubated patient) after
surgery

- Person under tutorship or curatorship

- Pregnancy

- Breastfeeding

NCT03618082 - Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study (GOALDAN)

Informations générales
Etablissements
Critères
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