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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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ClinicalTrials.gov Identifier: NCT01550354
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment
Ankyloglossia Drug: administration of propofol Drug: administration of alfentanil Drug: administration of rocuronium

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Study Start Date : February 2012
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Propofol group
Intravenous administration of propofol 2 mg/kg before intubation
Drug: administration of propofol
intravenous administration of propofol 2 mg/kg before intubation
Active Comparator: Alfentanil group
Intravenous administration of alfentanil 14 μg/kg before intubation
Drug: administration of alfentanil
intravenous administration of alfentanil 14 μg/kg before intubation
Active Comparator: Rocuronium group
Intravenous administration of rocuronium 0.3 mg/kg before intubation
Drug: administration of rocuronium
Intravenous administration of rocuronium 0.3 mg/kg before intubation



Primary Outcome Measures :
  1. Intubating condition [ Time Frame: Participants will be followed for the duration of intubation, an expected average of 1 minute. ]
    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.



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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01550354


Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01550354     History of Changes
Other Study ID Numbers: 4-2011-0824
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Ankyloglossia
Stomatognathic Diseases
Propofol
Alfentanil
Rocuronium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents