Neuromuscular BlockadeNCT06679569
Deep Neuromuscular Blockade on Postoperative Pain
A study testing rocuronium 0.2 mg/kg/hr continuous infusion and rocuronium 0.6 mg/kg/hr continuous infusion in people with Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 7 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- rocuronium 0.2 mg/kg/hr continuous infusion and rocuronium 0.6 mg/kg/hr continuous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2024to 7 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
SNUCH
Seoul, Seoul
Clinical Assistant, 82-2-2072-3664, snuh.pedane@gmail.com
About this study
Official title: Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial
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.
- Conditions
- Neuromuscular Blockade
- Being tested
- rocuronium 0.2 mg/kg/hr continuous infusion, rocuronium 0.6 mg/kg/hr continuous infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocuronium 0.2 mg/kg/hr continuous infusionDrug
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 infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| moderate neuromuscular blockade | Active comparator | Not described Receives: Drug: rocuronium 0.2 mg/kg/hr continuous infusion |
| deep neuromuscular blockade | Experimental | Not described Receives: Drug: rocuronium 0.6 mg/kg/hr continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANIm (Analgesia Nociception Index) Value
Measured: 30 minutes after arrival in the recovery room
Secondary outcomes (13)
FLACC Pain Scale
Measured: 30 minutes after arrival in the recovery room
Pediatric Anesthesia Emergence Delirium Scale
Measured: 30 minutes after arrival in the recovery room
Time to Extubation
Measured: From end of surgery to extubation (in minutes, assessed up to 1 hour)
Recovery Room Length of Stay
Measured: Duration of stay in the recovery room (in minutes, assessed up to 2 hours)
Remifentanil Consumption During Anesthesia
mcg/kg/min
Measured: During surgery ( assessed up to 5 hours)
Change in Pain Score (FLACC Pain Scale)
Measured: Every 6 hours up to 24 hours post-surgery
Maximum Pain Score (FLACC Pain Scale) within 24 Hours
Measured: Within 24 hours post-surgery
Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight
Measured: Within 24 hours post-surgery
Peak Intraabdominal Pressure During Surgery
Measured: During surgery (assessed up to 5 hours)
Peak Inspiratory Pressure During Surgery
Measured: During surgery (assessed up to 5 hours)
Leiden Surgical Rating Scale
Measured: During surgery (assessed up to 5 hours)
Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)
Measured: During recovery room stay (assessed up to 2 hours)
Any complications Occurring Before Discharge
Measured: Up to discharge (assessed up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start6 Nov 2024
- Primary completion6 Nov 2026 (estimated)
- Study completion7 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679569
- Sponsor's protocol ID
- 2410-015-1575
- Status last verified
- May 2025
- First submitted
- 4 Nov 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No