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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084031
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment Phase
Pediatric Urinary Disorders Drug: propofol Not Applicable

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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
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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

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%)

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

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.

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 identifier (NCT number): NCT01084031

Sponsors and Collaborators
Yonsei University
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Principal Investigator: Hae Keum Kil Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
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Responsible Party: Yonsei University Identifier: NCT01084031    
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:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General