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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
  Purpose

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 Intervention
Ankyloglossia
Drug: administration of propofol
Drug: administration of alfentanil
Drug: administration of rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Enrollment: 114
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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: NCT01550354

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

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01550354     History of Changes
Other Study ID Numbers: 4-2011-0824
Study First Received: February 22, 2012
Last Updated: February 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on November 20, 2014