NCT03618082

GOAL-Directed ANalgesia (GOALDAN)

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Immediate Severe Postoperative Pain
• Perioperative Hemodynamic

Interventions

Type	Name	Description
DRUG	Anesthesic agent guided by ANI (Interventional Group)	Anesthesic agent guided by ANI (Interventional Group) The remifentanil administration will be piloted by the ANI, as well as the prophylactic administration of morphine at the end of the intervention.
DRUG	Administration of the lowest effective concentration of desflurane (Interventional Group)	Administration of the lowest effective concentration of desflurane (Interventional Group) Desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).

Timeline

• Start date: 2019-06-06
• Primary completion: 2022-05-13
• Completion: 2022-08-13
• First posted: 2018-08-07
• Last updated: 2020-07-07

Locations

1 site across 1 country: France