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NCT03618082: GOALDAN

GOAL-Directed ANalgesia (GOALDAN)

Status unknown Phase 3 Last updated 7 July 2020
What this trial tests

Phase 3 trial testing Anesthesic agent guided by ANI (Interventional Group) in Immediate Severe Postoperative Pain in 380 participants. Status unknown.

Timeline
6 June 2019
Primary endpoint
13 May 2022
13 August 2022

Quick facts

Lead sponsorUniversity Hospital, Clermont-Ferrand
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment380
Start date6 June 2019
Primary completion13 May 2022
Estimated completion13 August 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Clermont-Ferrand

Who can join

Adults 18 to 65, any sex, with Immediate Severe Postoperative Pain or Perioperative Hemodynamic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of GOAL-Directed ANalgesia using ANI (Analgesia/Nociception Index) during general anesthesia on immediate postoperative pain and intraoperative hemodynamics in adult patients (GOALDAN study): a study protocol for randomized, controlled, multicenter trial.
    Michalot A, Bazin JÉ, Richebé P, Allaouchiche B, et al · · 2022 · cited 9× · PMID 35468803 · DOI 10.1186/s13063-022-06273-1

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