Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJune 7, 2021
June 1, 2021
1.9 years
February 22, 2012
June 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Intubating condition
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.
Participants will be followed for the duration of intubation, an expected average of 1 minute.
Study Arms (3)
Propofol group
ACTIVE COMPARATORIntravenous administration of propofol 2 mg/kg before intubation
Alfentanil group
ACTIVE COMPARATORIntravenous administration of alfentanil 14 μg/kg before intubation
Rocuronium group
ACTIVE COMPARATORIntravenous administration of rocuronium 0.3 mg/kg before intubation
Interventions
intravenous administration of propofol 2 mg/kg before intubation
intravenous administration of alfentanil 14 μg/kg before intubation
Intravenous administration of rocuronium 0.3 mg/kg before intubation
Eligibility Criteria
You may qualify if:
- Children, 1-9 years old scheduled elective frenectomy under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance hospital
Seoul, South Korea
Related Publications (1)
Park S, Kim JH, Bae JC, Lee JR, Kim MS. Tracheal intubation with or without a neuromuscular blocking agent for a short surgical procedure in children: Prospective, randomized, double-blind trial. Paediatr Anaesth. 2021 Aug;31(8):863-870. doi: 10.1111/pan.14205. Epub 2021 Jun 3.
PMID: 33993571BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
March 12, 2012
Study Start
February 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
June 7, 2021
Record last verified: 2021-06