RCVB: Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03060707

Collaborator

(none)

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Relaxation Anesthesia	Drug: Rocuronium Bromide	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial

Actual Study Start Date :

Mar 23, 2017

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Mar 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rocuronium dose per kilogram per hour [end of the surgery]
Total dose of rocuronium injected during surgery, divided by patient body weight and anesthesia time.

Secondary Outcome Measures

Desaturation event [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).
Surgical rating scale [end of the surgery]
Numerical scale describing how easy it is for surgeon to access surgical field, ranging from1 to 5

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SNUH	Seoul	Jongro Gu	Korea, Republic of	15710

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hee-Soo Kim, Prof., Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03060707

Other Study ID Numbers:

H1612-115-817

First Posted:

Feb 23, 2017

Last Update Posted:

Apr 26, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bromides

Rocuronium

Study Results

No Results Posted as of Apr 26, 2017