Status:
COMPLETED
POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Scoliosis Idiopathic
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief Summary
Anaesthesia is often performed using a balanced technique by administering both opioids and anaesthetics agents. Intraoperative opioid administration is still relying on simple parameters such as hear...
Detailed Description
Anaesthesia is often performed using a balanced technique by administering both opioids and anaesthetics agents. Intraoperative opioid administration is still relying on simple parameters such as hear...
Eligibility Criteria
Inclusion
- Age \< 18 years at time of surgery;
- Surgical correction of idiopathic scoliosis with or without thoracoplasty;
- Weight ≥ 30 kg : in order to allow using target plasma concentration administration of the opioid (remifentanil) and anaesthetic (propofol) agents; (pharmacokinetics models are not validated under this weight) during the intraoperative period;
- ASA (American Society of Anesthesiologist) status I to III
- Affiliation to the French national health insurance
Exclusion
- Second time of a scoliosis correction in the preceding year (apart the use of halo-gravity traction or non-painful procedures such as digestive endoscopy);
- Chronic treatment (\> 3 months) with: opioid agents, anti-epileptic agents or anti-depressant agents;
- Bad French language understanding;
- Expected difficulties in self-managing pain using the patient-controlled analgesia devices;
- ASA (American Society of Anesthesiologist) status IV or V;
- Any contraindication to one of the compound of the study: propofol, remifentanil, atracurium, paracetamol, Non-steroidal anti-inflammatory agents.
- Patients with a heart pace-maker device
- Patient under anti-arrythmic treatment
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04047225
Start Date
October 26 2020
End Date
December 26 2023
Last Update
January 7 2026
Active Locations (1)
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1
Department of Anesthesiology, Robert Debre University Hospital
Paris, France, 75019