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

June 3, 2021 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubating condition
Time Frame: Participants 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.
Participants will be followed for the duration of intubation, an expected average of 1 minute.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (ESTIMATE)

March 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0824

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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