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Clinical Trials/NCT06679569
NCT06679569RecruitingNot Applicable

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

Seoul National University Hospital1 site in 1 country106 target enrollmentStarted: November 6, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
106
Locations
1
Primary Endpoint
ANIm (Analgesia Nociception Index) Value
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
2 Months to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

moderate neuromuscular blockade

Active Comparator

Intervention: rocuronium 0.2 mg/kg/hr continuous infusion (Drug)

deep neuromuscular blockade

Experimental

Intervention: rocuronium 0.6 mg/kg/hr continuous infusion (Drug)

Outcomes

Primary Outcomes

ANIm (Analgesia Nociception Index) Value

Time Frame: 30 minutes after arrival in the recovery room

Secondary Outcomes

  • 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))
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ji-Hyun Lee

Professor

Seoul National University Hospital

Study Sites (1)

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