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

Respiratory Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919203
• Other study ID #: apsj0723
• Status: Completed
• Phase: N/A
• First received: August 7, 2013
• Last updated: July 14, 2015
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yeungnam University hospital	Nam gu	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Sangjin Park

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes