Deep Neuromuscular Blockade on Postoperative Pain

NCT06679569 | Recruiting DMC

• 1 other identifier: 2410-015-1575
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• ANIm (Analgesia Nociception Index) Value

  30 minutes after arrival in the recovery room

Secondary Outcomes (13)

• 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)

Study Arms (2)

moderate neuromuscular blockade

ACTIVE COMPARATOR

Drug: rocuronium 0.2 mg/kg/hr continuous infusion

deep neuromuscular blockade

EXPERIMENTAL

Drug: rocuronium 0.6 mg/kg/hr continuous infusion

Interventions

rocuronium 0.2 mg/kg/hr continuous infusion DRUG

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.

moderate neuromuscular blockade

rocuronium 0.6 mg/kg/hr continuous infusion DRUG

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.

deep neuromuscular blockade

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

SNUCH

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Clinical Assistant

CONTACT

82-2-2072-3664; snuh.pedane@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 7, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

KR (1)