Deep Neuromuscular Blockade on Postoperative Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: rocuronium 0.2 mg/kg/hr continuous infusion; Drug: rocuronium 0.6 mg/kg/hr continuous infusion

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Assistant; Phone Number: 82-2-2072-3664; Email: snuh.pedane@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • SNUCH
    • Contact: Clinical Assistant; Phone Number: 82-2-2072-3664; Email: snuh.pedane@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: moderate neuromuscular blockade	Drug: rocuronium 0.2 mg/kg/hr continuous infusion; To maintain Train-of-four count 1 to 3 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.2 mg/kg/hr to achieve and sustain moderate neuromuscular blockade.
Experimental: deep neuromuscular blockade	Drug: rocuronium 0.6 mg/kg/hr continuous infusion; To maintain Train-of-four count 0 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.6 mg/kg/hr to achieve and sustain deep neuromuscular blockade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ANIm (Analgesia Nociception Index) Value	30 minutes after arrival in the recovery room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	mcg/kg/min	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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 7, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 2410-015-1575

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No