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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03060707
Other study ID # H1612-115-817
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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