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Recruiting NCT06679569

Deep Neuromuscular Blockade on Postoperative Pain

No phase Interventional Neuromuscular Blockade

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rocuronium 0.2 mg/kg/hr continuous infusion, rocuronium 0.6 mg/kg/hr continuous infusion.
Who it may be relevant to
Registry conditions: Neuromuscular Blockade. Basic parameters: 2 months — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • ANIm (Analgesia Nociception Index) Value [Time frame: 30 minutes after arrival in the recovery room]
Secondary outcome measures (12)
  • 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 [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 [Time frame: During surgery (assessed up to 5 hours)]
  • Leiden Surgical Rating Scale [Time frame: During surgery (assessed up to 5 hours)]
  • Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement) [Time frame: During recovery room stay (assessed up to 2 hours)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • SNUCH — Seoul

Identifiers

NCT: NCT06679569 · 2410-015-1575

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗