Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
This study has been completed.
Information provided by (Responsible Party):
First received: March 5, 2010
Last updated: February 17, 2014
Last verified: February 2014
Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.
Pediatric Urinary Disorders
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
||Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
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%)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
intravenous propofol with sevoflurane inhalation induction
|Ages Eligible for Study:
||6 Months to 5 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Pediatric patients scheduled for elective day case surgery were enrolled.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01084031
||Hae Keum Kil
||Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2010
||February 17, 2014
||Korea: Food and Drug Administration
Korea: Ministry for Health and Welfare
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 26, 2016
Central Nervous System Depressants
Hypnotics and Sedatives
Physiological Effects of Drugs
Platelet Aggregation Inhibitors