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Remifentanil Requirement for Acceptable Intubating Condition

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ClinicalTrials.gov Identifier: NCT02655380
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
yun jeong chae, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 14, 2016
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE June 19, 2017
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remifentanil Requirement for Acceptable Intubating Condition
Official Title  ICMJE Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Intubating Condition
Intervention  ICMJE
  • Drug: Ketamine 1
    Anesthesia induction is performed with 1 mg ketamine.
  • Drug: Ketamine 2
    Anesthesia induction is performed with 2 mg ketamine.
  • Drug: Remifentanil
    After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.
Study Arms  ICMJE
  • Experimental: ketamine 1
    Anesthesia induction with ketamine 1 mg followed by remifentanil.
    Interventions:
    • Drug: Ketamine 1
    • Drug: Remifentanil
  • Experimental: ketamine 2
    Anesthesia induction with ketamine 2 mg followed by remifentanil.
    Interventions:
    • Drug: Ketamine 2
    • Drug: Remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
60
Actual Study Completion Date  ICMJE April 16, 2018
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02655380
Other Study ID Numbers  ICMJE MED-DRU-15-354
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party yun jeong chae, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: yun jeong chae, Ph.D Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP