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

Not Applicable

Completed

• Conditions: Respiratory Complication
• Interventions: Drug: Remifentanil

• Registration Number: NCT01919203
• Lead Sponsor: Sangjin Park

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group R	Remifentanil	The starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg.

Primary Outcome Measures

Name	Time	Method
patients's response to the LMA insertion	2 minutes after LMA insertion	Fail of LMA insertion is defined as body or limb movement, coughing or gagging with 2 minutes after LMA insertion, no proper jaw relaxation(difficult mouth opening), laryngospasm, bronchospasm, desaturation(SpO2\<94%)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital; 🇰🇷 Nam gu, Daegu, Korea, Republic of