Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

NCT ID: NCT03060707

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

comparing the total dose of rocuronium between continuous infusion and intermittent injection

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Relaxation Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Continuous infusion

The group of participants who are designated to receive continuously infused rocuronium.

Group Type EXPERIMENTAL

Rocuronium Bromide

Intervention Type DRUG

Continuously infuse, or bolus administer rocuronium.

Bolus administration

The group of participants who are designated to receive bolus administered rocuronium.

Group Type ACTIVE_COMPARATOR

Rocuronium Bromide

Intervention Type DRUG

Continuously infuse, or bolus administer rocuronium.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rocuronium Bromide

Continuously infuse, or bolus administer rocuronium.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hee-Soo Kim

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SNUH

Seoul, Jongro Gu, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hee-Soo Kim, Prof.

Role: CONTACT

+82 02-2072-3659

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hee-Soo Kim, M.D., PhD

Role: primary

82-2-2072-3659

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30540640 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H1612-115-817

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.