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

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ClinicalTrials.gov Identifier: NCT01084031
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.

Condition or disease Intervention/treatment
Pediatric Urinary Disorders Drug: propofol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
Study Start Date : November 2009
Primary Completion Date : February 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: propofol Drug: propofol
intravenous propofol with sevoflurane inhalation induction


Outcome Measures

Primary Outcome Measures :
  1. Assessment of intubation conditions [ Time Frame: 30 minutes after the surgery ]

    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%)



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01084031     History of Changes
Other Study ID Numbers: 4-2009-0470
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

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