GOAL-Directed ANalgesia (GOALDAN)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3

Conditions: Perioperative Hemodynamic; Immediate Severe Postoperative Pain

Treatments: Drug: Administration of the lowest effective concentration of desflurane (Interventional Group); Drug: Anesthesic agent guided by ANI (Interventional Group)

Study type: Interventional

Funder types: Other

Identifiers

NCT03618082

CHU-401

2017-A03268-45 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 2 patient groups

usual practice

Active Comparator group

Description:

control group (usual practice): patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance. The dosage of the anesthetic agent, as well as the prophylactic administration of morphine at the end of the intervention, will be decided by the anesthesiologist.

Treatment:

Drug: Anesthesic agent guided by ANI (Interventional Group)

Drug: Administration of the lowest effective concentration of desflurane (Interventional Group)

targeted analgesia to ANI

Experimental group

Description:

experimental group: patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance, as well as the prophylactic administration of morphine at the end of the intervention, will be administered according to the ANI. - In addition, desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).

Treatment:

Drug: Anesthesic agent guided by ANI (Interventional Group)

Drug: Administration of the lowest effective concentration of desflurane (Interventional Group)