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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01919203

Enrollment

Registered

2013-08-08

Start date

2013-08-31

Completion date

2015-07-31

Last updated

2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Complication

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.

Interventions

DRUGRemifentanil

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

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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%)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026