Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium (RCVB)

April 24, 2017 updated by: Hee-Soo Kim, Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Jongro Gu
      • Seoul, Jongro Gu, Korea, Republic of, 15710
        • Recruiting
        • SNUH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continuous infusion
The group of participants who are designated to receive continuously infused rocuronium.
Drug: Rocuronium Bromide
Continuously infuse, or bolus administer rocuronium.
ACTIVE_COMPARATOR: Bolus administration
The group of participants who are designated to receive bolus administered rocuronium.
Drug: Rocuronium Bromide
Continuously infuse, or bolus administer rocuronium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation event
Time Frame: Right after the patient is transferred to the ward, from PACU (1 day)
Whether the participant's peripheral oxygen saturation (SpO2) decreased less than 93%, in postanesthesia care unit (PACU).
Right after the patient is transferred to the ward, from PACU (1 day)
Surgical rating scale
Time Frame: end of the surgery
Numerical scale describing how easy it is for surgeon to access surgical field, ranging from1 to 5
end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2017

Primary Completion (ANTICIPATED)

November 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

February 19, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1612-115-817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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