Clinical trial NCT06679569: Deep Neuromuscular Blockade on Postoperative Pain
Official title: Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Blockade
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 106
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: ANIm (Analgesia Nociception Index) Value
timeFrame: 30 minutes after arrival in the recovery room
Secondary outcomes:
measure: FLACC Pain Scale
timeFrame: 30 minutes after arrival in the recovery room
measure: Pediatric Anesthesia Emergence Delirium Scale
timeFrame: 30 minutes after arrival in the recovery room
measure: Time to Extubation
timeFrame: From end of surgery to extubation (in minutes, assessed up to 1 hour)
measure: Recovery Room Length of Stay
timeFrame: Duration of stay in the recovery room (in minutes, assessed up to 2 hours)
measure: Remifentanil Consumption During Anesthesia
timeFrame: During surgery ( assessed up to 5 hours)
measure: Change in Pain Score (FLACC Pain Scale)
timeFrame: Every 6 hours up to 24 hours post-surgery
measure: Maximum Pain Score (FLACC Pain Scale) within 24 Hours
timeFrame: Within 24 hours post-surgery
measure: Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight
timeFrame: Within 24 hours post-surgery
measure: Peak Intraabdominal Pressure During Surgery
timeFrame: During surgery (assessed up to 5 hours)
measure: Peak Inspiratory Pressure During Surgery
timeFrame: During surgery (assessed up to 5 hours)
measure: Leiden Surgical Rating Scale
timeFrame: During surgery (assessed up to 5 hours)
measure: Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)
timeFrame: During recovery room stay (assessed up to 2 hours)
measure: Any complications Occurring Before Discharge
timeFrame: Up to discharge (assessed up to 1 month)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUCH
Study officials:
References: