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

NCT02646709 | Unknown Phase 4

• 1 other identifier: AJIRB-MED-CT4-15-153
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing

  during and after intubation, about 2 minute

Secondary Outcomes (9)

• heart rate

  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)

  5 min after postanesthesia care unit (PACU) admission

• PACU time

  from PACU admission to discharge, about 30 min

• severity of vomiting

  1. 1 min after PACU admission 2. 30 min after PACU admission

Study Arms (3)

Ketamine 1

EXPERIMENTAL

Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.

Drug: Rocuronium; Drug: ketamine 1

Ketamine 1.5

EXPERIMENTAL

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; Drug: ketamine 1.5

Ketamine 2

EXPERIMENTAL

Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.

Drug: Rocuronium; Drug: ketamine 2

Interventions

Rocuronium DRUG

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

Ketamine 1; Ketamine 1.5; Ketamine 2

ketamine 1 DRUG

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

Ketamine 1

ketamine 1.5 DRUG

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

Ketamine 1.5

ketamine 2 DRUG

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

Ketamine 2

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA class I, II

You may not qualify if:

• upper respiratory infection within 14 days
• anticipated difficult intubation

Sponsors & Collaborators

• Ajou University School of Medicine: lead

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Go Un Roh, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Go Un Roh, MD

CONTACT

82-31-219-6435; gone7968@aumc.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 6, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share