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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02646709
• Other study ID #: AJIRB-MED-CT4-15-153
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 28, 2015
• Last updated: January 4, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: January 2016
• Source: Ajou University School of Medicine
• Contact: Go Un Roh, MD
• Phone: 82-31-219-6435
• Email: gone7968[@]aumc.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• ASA class I, II

Exclusion Criteria:

• upper respiratory infection within 14 days

• anticipated difficult intubation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Rocuronium
Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.
• ketamine 1
ketamine 1 mg/kg will be injected for induction of anesthesia
• ketamine 1.5
ketamine 1.5 mg/kg will be injected for induction of anesthesia
• ketamine 2
ketamine 2 mg/kg will be injected for induction of anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	time for extubation		from the end of surgery to extubation, within 10 min	No
Secondary	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	No
Secondary	PACU time		from PACU admission to discharge, about 30 min	No
Secondary	severity of vomiting	severity(0-10)	1. 1 min after PACU admission 2. 30 min after PACU admission	No
Secondary	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	No
Secondary	Desaturation	pulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded.	during PACU stay, about 30 min	No
Secondary	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	No
Secondary	frequency of vomiting		1. 1 min after PACU admission 2. 30 min after PACU admission	No