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

Primary Purpose

Ankyloglossia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
administration of propofol
administration of alfentanil
administration of rocuronium
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ankyloglossia

Eligibility Criteria

1 Year - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Propofol group

Alfentanil group

Rocuronium group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2012
Last Updated
June 3, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01550354
Brief Title
Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankyloglossia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
Intravenous administration of propofol 2 mg/kg before intubation
Arm Title
Alfentanil group
Arm Type
Active Comparator
Arm Description
Intravenous administration of alfentanil 14 μg/kg before intubation
Arm Title
Rocuronium group
Arm Type
Active Comparator
Arm Description
Intravenous administration of rocuronium 0.3 mg/kg before intubation
Intervention Type
Drug
Intervention Name(s)
administration of propofol
Intervention Description
intravenous administration of propofol 2 mg/kg before intubation
Intervention Type
Drug
Intervention Name(s)
administration of alfentanil
Intervention Description
intravenous administration of alfentanil 14 μg/kg before intubation
Intervention Type
Drug
Intervention Name(s)
administration of rocuronium
Intervention Description
Intravenous administration of rocuronium 0.3 mg/kg before intubation
Primary Outcome Measure Information:
Title
Intubating condition
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33993571
Citation
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.
Results Reference
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Learn more about this trial

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

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