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

January 4, 2016 updated by: Go Un Roh, Ajou University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA class I, II

Exclusion Criteria:

  • upper respiratory infection within 14 days
  • anticipated difficult intubation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Condition
Time Frame: during and after intubation, about 2 minute

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 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
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
Time Frame: from the end of surgery to extubation, within 10 min
from the end of surgery to extubation, within 10 min
emergence agitation (4 points scale)
Time Frame: 5 min after postanesthesia care unit (PACU) admission

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
Time Frame: from PACU admission to discharge, about 30 min
from PACU admission to discharge, about 30 min
severity of vomiting
Time Frame: 1. 1 min after PACU admission 2. 30 min after PACU admission
severity(0-10)
1. 1 min after PACU admission 2. 30 min after PACU admission
Analgesic requirements (mg/kg)
Time Frame: during PACU stay, about 30 min
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
Time Frame: during PACU stay, about 30 min
pulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded.
during PACU stay, about 30 min
blood pressure
Time Frame: 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
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
Time Frame: 1. 1 min after PACU admission 2. 30 min after PACU admission
1. 1 min after PACU admission 2. 30 min after PACU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Go Un Roh, MD, Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-15-153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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