Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium
RCVB
Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
March 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 26, 2017
April 1, 2017
7 months
February 19, 2017
April 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Rocuronium dose per kilogram per hour
Total dose of rocuronium injected during surgery, divided by patient body weight and anesthesia time.
end of the surgery
Secondary Outcomes (2)
Desaturation event
Right after the patient is transferred to the ward, from PACU (1 day)
Surgical rating scale
end of the surgery
Study Arms (2)
Continuous infusion
EXPERIMENTALThe group of participants who are designated to receive continuously infused rocuronium.
Bolus administration
ACTIVE COMPARATORThe group of participants who are designated to receive bolus administered rocuronium.
Interventions
Continuously infuse, or bolus administer rocuronium.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUH
Seoul, Jongro Gu, 15710, South Korea
Related Publications (1)
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.
PMID: 30540640DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
February 19, 2017
First Posted
February 23, 2017
Study Start
March 23, 2017
Primary Completion
November 1, 2017
Study Completion
March 1, 2018
Last Updated
April 26, 2017
Record last verified: 2017-04