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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Drug: Rocuronium
* Drug: ketamine 1
* Drug: ketamine 1.5
* Drug: ketamine 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I, II Exclusion Criteria: upper respiratory infection within 14 days anticipated difficult intubation

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine 1<br>Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. | Drug: Rocuronium<br>* Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.<br>Drug: ketamine 1<br>* ketamine 1 mg/kg will be injected for induction of anesthesia<br>|
| Experimental: Ketamine 1.5<br>Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. | Drug: Rocuronium<br>* Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.<br>Drug: ketamine 1.5<br>* ketamine 1.5 mg/kg will be injected for induction of anesthesia<br>|
| Experimental: Ketamine 2<br>Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation. | Drug: Rocuronium<br>* Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.<br>Drug: ketamine 2<br>* ketamine 2 mg/kg will be injected for induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Condition | 5 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. Laryngoscope easiness Vocal cord position Vocal cord movement Movement of limb Coughing | during and after intubation, about 2 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate will be recorded. | 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation | 
| time for extubation |  | from the end of surgery to extubation, within 10 min | 
| emergence agitation (4 points scale) | 4 points scale 1: calm 2. cry but manageable 3. cry, not manageable 4. excitation | 5 min after postanesthesia care unit (PACU) admission | 
| PACU time |  | from PACU admission to discharge, about 30 min | 
| severity of vomiting | severity(0-10) | 1. 1 min after PACU admission 2. 30 min after PACU admission | 
| Analgesic requirements (mg/kg) | if pain score exceed 3, fentanyl will be introduced. The total dose of fentanyl injection will be recorded. | during PACU stay, about 30 min | 
| Desaturation | pulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded. | during PACU stay, about 30 min | 
| blood pressure | blood pressure will be recorded | 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation | 
| frequency of vomiting |  | 1. 1 min after PACU admission 2. 30 min after PACU admission |