Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

Overview

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.

Full Title of Study: “Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 2017

Detailed Description

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

Interventions

  • Drug: Rocuronium Bromide
    • Continuously infuse, or bolus administer rocuronium.

Arms, Groups and Cohorts

  • Experimental: Continuous infusion
    • The group of participants who are designated to receive continuously infused rocuronium.
  • Active Comparator: Bolus administration
    • The group of participants who are designated to receive bolus administered rocuronium.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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).
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hee-Soo Kim, Prof. – Seoul National University Hospital
  • Overall Contact(s)
    • Hee-Soo Kim, Prof., +82 02-2072-3659, dami0605@snu.ac.kr

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