Deep Neuromuscular Blockade on Postoperative Pain

Not Applicable

Recruiting

• Conditions: Neuromuscular Blockade
• Interventions: Drug: rocuronium 0.2 mg/kg/hr continuous infusion; Drug: rocuronium 0.6 mg/kg/hr continuous infusion

• Registration Number: NCT06679569
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study Start: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-11-06
• Study Completion: 2026-11-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate neuromuscular blockade	rocuronium 0.2 mg/kg/hr continuous infusion	-
deep neuromuscular blockade	rocuronium 0.6 mg/kg/hr continuous infusion	-

Primary Outcome Measures

Name	Time	Method
ANIm (Analgesia Nociception Index) Value	30 minutes after arrival in the recovery room

Secondary Outcome Measures

Name	Time	Method
Any complications Occurring Before Discharge	Up to discharge (assessed up to 1 month)
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)	mcg/kg/min
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)
FLACC Pain Scale	30 minutes after arrival in the recovery room
Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)	During recovery room stay (assessed up to 2 hours)

Trial Locations

Locations (1)

SNUCH; 🇰🇷 Seoul, Korea, Republic of