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NCT Number: NCT06679569

Deep Neuromuscular Blockade on Postoperative Pain

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

2 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. ANIm (Analgesia Nociception Index) Value

    Time frame: 30 minutes after arrival in the recovery room

Secondary outcomes

  1. FLACC Pain Scale

    Time frame: 30 minutes after arrival in the recovery room

  2. Pediatric Anesthesia Emergence Delirium Scale

    Time frame: 30 minutes after arrival in the recovery room

  3. Time to Extubation

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

  4. Recovery Room Length of Stay

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

  5. Remifentanil Consumption During Anesthesia

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

    mcg/kg/min

  6. Change in Pain Score (FLACC Pain Scale)

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

  7. Maximum Pain Score (FLACC Pain Scale) within 24 Hours

    Time frame: Within 24 hours post-surgery

  8. Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight

    Time frame: Within 24 hours post-surgery

  9. Peak Intraabdominal Pressure During Surgery

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

  10. Peak Inspiratory Pressure During Surgery

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

  11. Leiden Surgical Rating Scale

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

  12. Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)

    Time frame: During recovery room stay (assessed up to 2 hours)

  13. Any complications Occurring Before Discharge

    Time frame: Up to discharge (assessed up to 1 month)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Assistant

CONTACT

[email protected]

82-2-2072-3664

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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