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Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01084031
First received: March 5, 2010
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.


Condition Intervention
Pediatric Urinary Disorders
 Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Assessment of intubation conditions [ Time Frame: 30 minutes after the surgery ] [ Designated as safety issue: No ]

    Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods.

    peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%)



Enrollment: 50
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: propofol Drug: propofol
intravenous propofol with sevoflurane inhalation induction

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients scheduled for elective day case surgery were enrolled.

Exclusion Criteria:

  • History of obstructive sleep apnea
  • Evidence of cardiorespiratory disease
  • Those who were obese or allergic to any of the anesthetic agents in this study
  • Those with an anticipated difficult airway, full stomach
  • History of malignant hyperthermia or other myopathy were excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084031

Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hae Keum Kil Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01084031     History of Changes
Other Study ID Numbers: 4-2009-0470
Study First Received: March 5, 2010
Last Updated: March 4, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:
Propofol
Sevoflurane
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 19, 2013