Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01550354
First received: February 22, 2012
Last updated: February 4, 2014
Last verified: February 2014

February 22, 2012
February 4, 2014
February 2012
January 2014   (final data collection date for primary outcome measure)
Intubating condition [ Time Frame: Participants will be followed for the duration of intubation, an expected average of 1 minute. ] [ Designated as safety issue: No ]
The investigators will perform the evaluation of intubating condtion through scoring system provided by Viby-Mogensen during intubation procedure. The scoring system is consisted of excellent, good, and poor.
Same as current
Complete list of historical versions of study NCT01550354 on ClinicalTrials.gov Archive Site
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Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy
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Several methods have been demonstrated to improve intubating conditions during sevoflurane induction in children. These include opioids, propofol, and addition of neuromuscular blocking agents in pediatric patients. But the study about the comparison of these agents has been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure performed under general anesthesia. The investigators aimed to compare intubating conditions among children with propofol, alfentanil or rocuronium after sevoflurane induction.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Ankyloglossia
  • Drug: administration of propofol
    intravenous administration of propofol 2 mg/kg before intubation
  • Drug: administration of alfentanil
    intravenous administration of alfentanil 14 μg/kg before intubation
  • Drug: administration of rocuronium
    Intravenous administration of rocuronium 0.3 mg/kg before intubation
  • Active Comparator: Propofol group
    Intravenous administration of propofol 2 mg/kg before intubation
    Intervention: Drug: administration of propofol
  • Active Comparator: Alfentanil group
    Intravenous administration of alfentanil 14 μg/kg before intubation
    Intervention: Drug: administration of alfentanil
  • Active Comparator: Rocuronium group
    Intravenous administration of rocuronium 0.3 mg/kg before intubation
    Intervention: Drug: administration of rocuronium
Devys JM, Mourissoux G, Donnette FX, Plat R, Schauvliège F, Le Bigot P, Dureau P, Plaud B. Intubating conditions and adverse events during sevoflurane induction in infants. Br J Anaesth. 2011 Feb;106(2):225-9. doi: 10.1093/bja/aeq346. Epub 2010 Dec 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children, 1-9 years old scheduled elective frenectomy under general anesthesia

Exclusion Criteria:

  • Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
Both
1 Year to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01550354
4-2011-0824
Yes
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP