Actively Recruiting
Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial
Led by Seoul National University Hospital · Updated on 2025-05-13
106
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate how different levels of neuromuscular blockade affect postoperative pain in children aged over 2 months to under 7 years undergoing laparoscopic surgery with general anesthesia. The study focuses on understanding pain control in this young patient group during recovery after surgery. The trial is a prospective randomized controlled study led by Seoul National University Hospital. Participants will receive either a moderate or deep neuromuscular blockade during surgery. Moderate blockade is maintained by a continuous infusion of rocuronium at 0.2 mg/kg/hr to keep the Train-of-four count between 1 and 3, while deep blockade uses a higher infusion rate of 0.6 mg/kg/hr to achieve a Train-of-four count of 0. These two groups will be compared to assess differences in pain and recovery. Throughout the study, children will be closely monitored after surgery with assessments including the Analgesia Nociception Index 30 minutes after arrival in the recovery room, pain scales, emergence delirium scores, time to extubation, recovery room stay length, and medication use. Additional monitoring includes surgical and respiratory parameters during surgery, as well as any complications up to one month after discharge. The study will collect detailed data on pain and recovery outcomes over a 24-hour period following surgery.
CONDITIONS
Brief Title
Deep Neuromuscular Blockade on Postoperative Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 hours (duration of surgery)
Participants receive continuous infusion of rocuronium to maintain neuromuscular blockade during laparoscopic surgery under general anesthesia.
1 surgical procedure visit (in-person)
Duration - Up to 1 month
Participants are monitored for postoperative pain, recovery, and any complications after surgery.
Visits within 24 hours post-surgery and additional assessments up to 1 month
Trial Site Locations
Total: 1 location
1
SNUCH
Seoul, Seoul, South Korea
Actively Recruiting
Research Team
C
Clinical Assistant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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