Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

Phase 4

• Conditions: Muscle Relaxation; Anesthesia
• Interventions: Drug: Rocuronium Bromide

• Registration Number: NCT03060707
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Study Start: 2017-03-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-11
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion	Rocuronium Bromide	The group of participants who are designated to receive continuously infused rocuronium.
Bolus administration	Rocuronium Bromide	The group of participants who are designated to receive bolus administered rocuronium.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of