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Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium (RCVB)

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Seoul National University

Status and phase

Unknown
Phase 4

Conditions

Anesthesia
Muscle Relaxation

Treatments

Drug: Rocuronium Bromide

Study type

Interventional

Funder types

Other

Identifiers

NCT03060707
H1612-115-817

Details and patient eligibility

About

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 description

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

Enrollment

70 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Continuous infusion
Experimental group
Description:
The group of participants who are designated to receive continuously infused rocuronium.
Treatment:
Drug: Rocuronium Bromide
Bolus administration
Active Comparator group
Description:
The group of participants who are designated to receive bolus administered rocuronium.
Treatment:
Drug: Rocuronium Bromide

Trial contacts and locations

1

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Central trial contact

Hee-Soo Kim, Prof.

Data sourced from clinicaltrials.gov

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