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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Complication
• Intervention / Treatment: Drug: Remifentanil

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu
    • Nam gu, Daegu, Korea, Republic of, 705-035
      • Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group R; The starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg.	Drug: 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.; Other Names: remifentanil (ultiva)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients's response to the 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%)	2 minutes after LMA insertion

Collaborators and Investigators

• Sponsor: Sangjin Park
• Investigators: Principal Investigator: Sangjin Park, M.D., Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 8, 2013

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: apsj0723