Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country106 target enrollmentNovember 6, 2024

ConditionsNeuromuscular Blockade

Interventionsrocuronium 0.2 mg/kg/hr continuous infusion rocuronium 0.6 mg/kg/hr continuous infusion

Drugsrocuronium 0.2 mg/kg/hr continuous infusion rocuronium 0.6 mg/kg/hr continuous infusion

Overview

Phase: Not Applicable
Intervention: rocuronium 0.2 mg/kg/hr continuous infusion
Conditions: Neuromuscular Blockade
Sponsor: Seoul National University Hospital
Enrollment: 106
Locations: 1
Primary Endpoint: ANIm (Analgesia Nociception Index) Value
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.

Registry

clinicaltrials.gov

Start Date

November 6, 2024

End Date

November 7, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Ji-Hyun Lee

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•Pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia.
•American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.

Exclusion Criteria

•Patients undergoing emergency surgery.
•Patients with chronic pain or currently taking analgesics for chronic pain.
•Known hypersensitivity to general anesthetic agents or analgesics.
•Patients with underlying cardiovascular disease.
•Patients with neuromuscular disorders.
•Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.

Arms & Interventions

moderate neuromuscular blockade

Intervention: rocuronium 0.2 mg/kg/hr continuous infusion

deep neuromuscular blockade

Intervention: rocuronium 0.6 mg/kg/hr continuous infusion

Outcomes

Primary Outcomes

ANIm (Analgesia Nociception Index) Value

Time Frame: 30 minutes after arrival in the recovery room

Secondary Outcomes

FLACC Pain Scale(30 minutes after arrival in the recovery room)
Pediatric Anesthesia Emergence Delirium Scale(30 minutes after arrival in the recovery room)
Time to Extubation(From end of surgery to extubation (in minutes, assessed up to 1 hour))
Recovery Room Length of Stay(Duration of stay in the recovery room (in minutes, assessed up to 2 hours))
Remifentanil Consumption During Anesthesia(During surgery ( assessed up to 5 hours))
Change in Pain Score (FLACC Pain Scale)(Every 6 hours up to 24 hours post-surgery)
Maximum Pain Score (FLACC Pain Scale) within 24 Hours(Within 24 hours post-surgery)
Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight(Within 24 hours post-surgery)
Peak Intraabdominal Pressure During Surgery(During surgery (assessed up to 5 hours))
Peak Inspiratory Pressure During Surgery(During surgery (assessed up to 5 hours))
Leiden Surgical Rating Scale(During surgery (assessed up to 5 hours))
Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)(During recovery room stay (assessed up to 2 hours))
Any complications Occurring Before Discharge(Up to discharge (assessed up to 1 month))