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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ankyloglossia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Propofol group

Intravenous administration of propofol 2 mg/kg before intubation

Group Type ACTIVE_COMPARATOR

administration of propofol

Intervention Type DRUG

intravenous administration of propofol 2 mg/kg before intubation

Alfentanil group

Intravenous administration of alfentanil 14 μg/kg before intubation

Group Type ACTIVE_COMPARATOR

administration of alfentanil

Intervention Type DRUG

intravenous administration of alfentanil 14 μg/kg before intubation

Rocuronium group

Intravenous administration of rocuronium 0.3 mg/kg before intubation

Group Type ACTIVE_COMPARATOR

administration of rocuronium

Intervention Type DRUG

Intravenous administration of rocuronium 0.3 mg/kg before intubation

Interventions

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administration of propofol

intravenous administration of propofol 2 mg/kg before intubation

Intervention Type DRUG

administration of alfentanil

intravenous administration of alfentanil 14 μg/kg before intubation

Intervention Type DRUG

administration of rocuronium

Intravenous administration of rocuronium 0.3 mg/kg before intubation

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No