the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Children

NCT ID: NCT01919203

Last Updated: 2015-07-16

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-07-31

Brief Summary

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This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.

Detailed Description

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Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.

Conditions

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Respiratory Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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group R

The starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.

Interventions

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Remifentanil

The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.

Intervention Type DRUG

Other Intervention Names

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remifentanil (ultiva)

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status 1 or 2
* undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia

Exclusion Criteria

* suspected difficult airways
* respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
* body mass index \> 30 kg/m2
* allergies to the study drugs
* a history of gastric reflux
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sangjin Park

OTHER

Sponsor Role lead

Responsible Party

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Sangjin Park

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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sangjin park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Locations

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Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Nam Gu, Daegu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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apsj0723

Identifier Type: -

Identifier Source: org_study_id

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