Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

Study Overview
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Brief Summary
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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
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comparing the total dose of rocuronium between continuous infusion and intermittent injection

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

Conditions
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Muscle Relaxation, Anesthesia

Intervention / Treatment
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* Drug: Rocuronium Bromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous infusion<br>The group of participants who are designated to receive continuously infused rocuronium. | Drug: Rocuronium Bromide<br>* Continuously infuse, or bolus administer rocuronium.<br>|
| Active Comparator: Bolus administration<br>The group of participants who are designated to receive bolus administered rocuronium. | Drug: Rocuronium Bromide<br>* Continuously infuse, or bolus administer rocuronium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation event | 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 | Numerical scale describing how easy it is for surgeon to access surgical field, ranging from1 to 5 | end of the surgery |