Deep Neuromuscular Blockade on Postoperative Pain

Seoul National University Hospital106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

106

Conditions

Neuromuscular Blockade

Interventions

rocuronium 0.2 mg/kg/hr continuous infusionDRUG

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.

rocuronium 0.6 mg/kg/hr continuous infusionDRUG

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

SNUCH

Seoul, Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

ANIm (Analgesia Nociception Index) Value

Time frame: 30 minutes after arrival in the recovery room

Secondary Outcomes

FLACC Pain Scale

Time frame: 30 minutes after arrival in the recovery room

Pediatric Anesthesia Emergence Delirium Scale

Time frame: 30 minutes after arrival in the recovery room

Time to Extubation

Time frame: From end of surgery to extubation (in minutes, assessed up to 1 hour)

Recovery Room Length of Stay

Time frame: Duration of stay in the recovery room (in minutes, assessed up to 2 hours)

Remifentanil Consumption During Anesthesia

mcg/kg/min

Time frame: During surgery ( assessed up to 5 hours)

Change in Pain Score (FLACC Pain Scale)

Time frame: Every 6 hours up to 24 hours post-surgery

Maximum Pain Score (FLACC Pain Scale) within 24 Hours

Time frame: Within 24 hours post-surgery

Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight

Time frame: Within 24 hours post-surgery

Peak Intraabdominal Pressure During Surgery

Time frame: During surgery (assessed up to 5 hours)

Peak Inspiratory Pressure During Surgery

Central Contacts

Clinical Assistant

CONTACT

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

Data from ClinicalTrials.gov

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