NCT01919203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

August 7, 2013

Last Update Submit

July 14, 2015

Conditions

Respiratory Complication

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

group R

EXPERIMENTAL

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

Drug: Remifentanil

Interventions

RemifentanilDRUG

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.

Also known as: remifentanil (ultiva)
group R

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Nam Gu, Daegu, 705-035, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • sangjin park, M.D.

    Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 8, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

KR(1)