Remifentanil Requirement for Acceptable Intubating Condition

January 8, 2019 updated by: yun jeong chae, Ajou University School of Medicine

Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children

Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

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.

Study Locations

  • Korea, Republic of
    • Gyeong-gi Do
      • Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
        • Ajou universitiy school of medicine

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

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • Undergoing general anesthesia with endotracheal tube

Exclusion Criteria:

  • Anticipated difficult airway
  • Patient with upper respiratory infection within 14 days
  • Asthma

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketamine 1
Anesthesia induction with ketamine 1 mg followed by remifentanil.
Drug: Ketamine 1
Anesthesia induction is performed with 1 mg ketamine.
Drug: Remifentanil
After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.
Experimental: ketamine 2
Anesthesia induction with ketamine 2 mg followed by remifentanil.
Drug: Remifentanil
After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.
Drug: Ketamine 2
Anesthesia induction is performed with 2 mg ketamine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acceptability of intubation condition
Time Frame: during and after intubation, about 2 minute

For assessment of 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. Good and excellent will be considered to be acceptable intubating condition. Poor will be reported as unacceptable intubating condition.

  1. Laryngoscope easiness
  2. Vocal cord position
  3. Vocal cord movement
  4. Movement of limb
  5. Coughing
during and after intubation, about 2 minute

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Study Director: yun jeong chae, Ph.D, 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 (Actual)

June 19, 2017

Primary Completion (Actual)

April 16, 2018

Study Completion (Actual)

April 16, 2018

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-DRU-15-354

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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