Muscle RelaxationPhase 4RCVBNCT03060707
Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium
A Phase 4 study testing Rocuronium Bromide in people with Muscle Relaxation and Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The research is to find out whether continuous infusion of rocuronium requires more or less amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during noncardiac surgery. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Muscle Relaxation, Anesthesia
- What is being tested?
- Rocuronium Bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2017to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged between 2 and 12, undergoing elective noncardiac surgery which requires general anesthesia but does not require intense block, and estimated time of surgery is between 2 and 5 hours
Who cannot join
- ASA class 3-6
- BMI >= 30
- Previous history of hepatic failure, renal failure or neuromuscular disease
- Patients taking medicine which interacts with rocuronium bromide, before or during surgery: aminoglycosides, lincosamides, acylamino-penicillin antibiotics, tetracyclines, metronidazole (high dose), diuretics, MAO inhibitors, calcium channel blockers, corticosteroids, phenytoin, carbamazepine, or norepinephrine
- Previous history of allergic reaction (including anaphylactic reaction) and/or malignant hyperthermia during general anesthesia
- Patients taking medicines which contains magnesium
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
SNUH
Seoul, Jongro Gu, 15710
Hee-Soo Kim, M.D., PhD, 82-2-2072-3659, dami0605@snu.ac.kr
About this study
Official title: Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial
The research is to find out whether continuous infusion of rocuronium requires more or less amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during noncardiac surgery.
Read the detailed description
comparing the total dose of rocuronium between continuous infusion and intermittent injection
- Conditions
- Muscle Relaxation, Anesthesia
- Being tested
- Rocuronium Bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium BromideDrug
Continuously infuse, or bolus administer rocuronium.
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Experimental | The group of participants who are designated to receive continuously infused rocuronium. Receives: Drug: Rocuronium Bromide |
| Bolus administration | Active comparator | The group of participants who are designated to receive bolus administered rocuronium. Receives: Drug: Rocuronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rocuronium dose per kilogram per hour
Total dose of rocuronium injected during surgery, divided by patient body weight and anesthesia time.
Measured: end of the surgery
Secondary outcomes (2)
Desaturation event
Whether the participant's peripheral oxygen saturation (SpO2) decreased less than 93%, in postanesthesia care unit (PACU).
Measured: Right after the patient is transferred to the ward, from PACU (1 day)
Surgical rating scale
Numerical scale describing how easy it is for surgeon to access surgical field, ranging from1 to 5
Measured: end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start23 Mar 2017
- Primary completionNov 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle RelaxationStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060707
- Sponsor's protocol ID
- H1612-115-817
- Acronym
- RCVB
- Status last verified
- Apr 2017
- First submitted
- 19 Feb 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi SN, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of rocuronium requirement in children with continuous infusion versus intermittent bolus: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):194-199. doi: 10.1097/EJA.0000000000000934.
PubMed 30540640
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03060707
- Acronym / sponsor ID
- RCVB / H1612-115-817
- Conditions
- Muscle Relaxation, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 23 Feb 2017 (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.
The research is to find out whether continuous infusion of rocuronium requires more or less amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during noncardiac surgery.
Detailed description
comparing the total dose of rocuronium between continuous infusion and intermittent injection
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Experimental | Drug: Rocuronium BromideThe group of participants who are designated to receive continuously infused rocuronium. |
| Bolus administration | Active comparator | Drug: Rocuronium BromideThe group of participants who are designated to receive bolus administered rocuronium. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged between 2 and 12, undergoing elective noncardiac surgery which requires general anesthesia but does not require intense block, and estimated time of surgery is between 2 and 5 hours
Key exclusion criteria (6 listed)
- ASA class 3-6
- BMI >= 30
- Previous history of hepatic failure, renal failure or neuromuscular disease
- Patients taking medicine which interacts with rocuronium bromide, before or during surgery: aminoglycosides, lincosamides, acylamino-penicillin antibiotics, tetracyclines, metronidazole (high dose), diuretics, MAO inhibitors, calcium channel blockers, corticosteroids, phenytoin, carbamazepine, or norepinephrine
- Previous history of allergic reaction (including anaphylactic reaction) and/or malignant hyperthermia during general anesthesia
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 BromideContinuously infuse, or bolus administer rocuronium. | Drug | Bolus administration, Continuous infusion |
Primary outcome
Rocuronium dose per kilogram per hour
Time frame: end of the surgery
Total dose of rocuronium injected during surgery, divided by patient body weight and anesthesia time.
2 secondary outcomes
Desaturation event
Time frame: Right after the patient is transferred to the ward, from PACU (1 day)
Surgical rating scale
Time frame: end of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 30540640Choi SN, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of rocuronium requirement in children with continuous infusion versus intermittent bolus: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):194-199. doi: 10.1097/EJA.0000000000000934.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium Bromide in people with Muscle Relaxation and Anesthesia, 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 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Soo Kim, Prof. (+82 02-2072-3659, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rocuronium dose per kilogram per hour (time frame: end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060707, which also lists 1 linked publication.
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 26 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.