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 (Child)
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 25, 2016
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors