Neuromuscular Blockade
Conditions
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.
Interventions
DRUGrocuronium 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.
DRUGrocuronium 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 7 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ANIm (Analgesia Nociception Index) Value | 30 minutes after arrival in the recovery room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | mcg/kg/min |
| 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 | — |
| FLACC Pain Scale | 30 minutes after arrival in the recovery room | — |
| 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) | — |
| Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight | Within 24 hours post-surgery | — |
Countries
South Korea
Contacts
Primary ContactClinical Assistant
Outcome results
None listed