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The Effect of Different Dose of Ketamine With Low Dose Rocuronium in Children

The Effect of Different Doses of Ketamine on Tracheal Intubating Conditions Using Low Dose Rocuronium in Children

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02646709
Enrollment
60
Registered
2016-01-06
Start date
2016-01-31
Completion date
2016-05-31
Last updated
2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Brief summary

Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.

Interventions

DRUGRocuronium

Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.

ketamine 1 mg/kg will be injected for induction of anesthesia

DRUGketamine 1.5

ketamine 1.5 mg/kg will be injected for induction of anesthesia

ketamine 2 mg/kg will be injected for induction of anesthesia

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* ASA class I, II

Exclusion criteria

* upper respiratory infection within 14 days * anticipated difficult intubation

Design outcomes

Primary

MeasureTime frameDescription
Intubation Conditionduring and after intubation, about 2 minute5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing

Secondary

MeasureTime frameDescription
time for extubationfrom the end of surgery to extubation, within 10 min
emergence agitation (4 points scale)5 min after postanesthesia care unit (PACU) admission4 points scale 1: calm 2. cry but manageable 3. cry, not manageable 4. excitation
PACU timefrom PACU admission to discharge, about 30 min
severity of vomiting1. 1 min after PACU admission 2. 30 min after PACU admissionseverity(0-10)
heart rate1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubationheart rate will be recorded.
Desaturationduring PACU stay, about 30 minpulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded.
blood pressure1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubationblood pressure will be recorded
frequency of vomiting1. 1 min after PACU admission 2. 30 min after PACU admission
Analgesic requirements (mg/kg)during PACU stay, about 30 minif pain score exceed 3, fentanyl will be introduced. The total dose of fentanyl injection will be recorded.

Contacts

Primary ContactGo Un Roh, MD
gone7968@aumc.ac.kr82-31-219-6435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026