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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01550354
Enrollment
114
Registered
2012-03-12
Start date
2012-02-29
Completion date
2014-01-31
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankyloglossia

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.

Interventions

intravenous administration of propofol 2 mg/kg before intubation

DRUGadministration of alfentanil

intravenous administration of alfentanil 14 μg/kg before intubation

DRUGadministration of rocuronium

Intravenous administration of rocuronium 0.3 mg/kg before intubation

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intubating conditionParticipants 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026