Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

Anesthesia Clinical Trial

— RCVB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060707
• Other study ID #: H1612-115-817
• Status: Recruiting
• Phase: Phase 4
• First received: February 19, 2017
• Last updated: April 24, 2017
• Start date: March 23, 2017
• Est. completion date: March 2018

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim, Prof.
• Phone: +82 02-2072-3659
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Muscle Relaxation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Surgical rating scale	Numerical scale describing how easy it is for surgeon to access surgical field, ranging from1 to 5	end of the surgery