ClinicalTrials.gg
CompletedNCT01550354Updated Jun 7, 2021

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

An interventional study of administration of propofol and administration of alfentanil in Ankyloglossia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Year to 9 Years. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by Yonsei University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
1 Year to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ankyloglossia

Browse trials for

03

In context

Ankyloglossia

32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.

This study's enrollment of 114 is close to the median of 105 across 22 interventional studies indexed under Ankyloglossia.

Browse Ankyloglossia studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
114 participants (actual)

Study arms

  • Active comparator
    Propofol group

    Intravenous administration of propofol 2 mg/kg before intubation

    Drug: administration of propofol

  • Active comparator
    Alfentanil group

    Intravenous administration of alfentanil 14 μg/kg before intubation

    Drug: administration of alfentanil

  • Active comparator
    Rocuronium group

    Intravenous administration of rocuronium 0.3 mg/kg before intubation

    Drug: administration of rocuronium

Interventions

  • Drugadministration of propofol

    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

06

What researchers measure

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.

    Time frame: Participants will be followed for the duration of intubation, an expected average of 1 minute.

07

Study locations

1 site
  • Severance hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 33993571 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01550354
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Feb 2012
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Jun 7, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion