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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06679569
- Acronym / sponsor ID
- 2410-015-1575
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 7 Nov 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate neuromuscular blockade | Active comparator | Drug: rocuronium 0.2 mg/kg/hr continuous infusion |
| deep neuromuscular blockade | Experimental | Drug: rocuronium 0.6 mg/kg/hr continuous infusion |
Who may qualify
- Ages
- 2 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rocuronium 0.2 mg/kg/hr continuous infusionTo 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. | Drug | moderate neuromuscular blockade |
| rocuronium 0.6 mg/kg/hr continuous infusionTo 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. | Drug | deep neuromuscular blockade |
Primary outcome
ANIm (Analgesia Nociception Index) Value
Time frame: 30 minutes after arrival in the recovery room
13 secondary outcomes
FLACC Pain Scale
Time frame: 30 minutes after arrival in the recovery room
Pediatric Anesthesia Emergence Delirium Scale
Time frame: 30 minutes after arrival in the recovery room
Time to Extubation
Time frame: From end of surgery to extubation (in minutes, assessed up to 1 hour)
Recovery Room Length of Stay
Time frame: Duration of stay in the recovery room (in minutes, assessed up to 2 hours)
Remifentanil Consumption During Anesthesia
Time frame: During surgery ( assessed up to 5 hours)
Change in Pain Score (FLACC Pain Scale)
Time frame: Every 6 hours up to 24 hours post-surgery
Maximum Pain Score (FLACC Pain Scale) within 24 Hours
Time frame: Within 24 hours post-surgery
Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight
Time frame: Within 24 hours post-surgery
Peak Intraabdominal Pressure During Surgery
Time frame: During surgery (assessed up to 5 hours)
Peak Inspiratory Pressure During Surgery
Time frame: During surgery (assessed up to 5 hours)
Leiden Surgical Rating Scale
Time frame: During surgery (assessed up to 5 hours)
Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)
Time frame: During recovery room stay (assessed up to 2 hours)
Any complications Occurring Before Discharge
Time frame: Up to discharge (assessed up to 1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Assistant (82-2-2072-3664, snuh.pedane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANIm (Analgesia Nociception Index) Value (time frame: 30 minutes after arrival in the recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.