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Clinical Trials/NCT01919203
NCT01919203CompletedNot Applicable

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

Sangjin Park1 site in 1 country50 target enrollmentStarted: August 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
patients's response to the LMA insertion

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
3 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

group R

Experimental

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

Intervention: Remifentanil (Drug)

Outcomes

Primary Outcomes

patients's response to the LMA insertion

Time Frame: 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%)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sangjin Park
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sangjin Park

assistant professor

Yeungnam University College of Medicine

Study Sites (1)

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