UnknownPhase 3Other

GOAL-Directed ANalgesia (GOALDAN)

NCT ID

NCT03618082

Target Enrollment

380 participants

Start Date

2019-06-06

Est. Completion

2022-08-13

About This Study

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.

Conditions Studied

Immediate Severe Postoperative PainPerioperative Hemodynamic

Interventions

•Anesthesic agent guided by ANI (Interventional Group)
•Administration of the lowest effective concentration of desflurane (Interventional Group)

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full eligibility criteria

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

Exclusion Criteria:

* 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

Study Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, France