NCT01152476

Brief Summary

Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

June 25, 2010

Last Update Submit

January 5, 2011

Conditions

Healthy

Keywords

healthy pediatric patients undergoing tonsillectomy and adenoidectomy

Outcome Measures

Primary Outcomes (1)

  • emergency agitation

    at post-anesthetic care unit

    during 1 hour after recovering of anesthesia

Study Arms (2)

group SR

ACTIVE COMPARATOR
Drug: remifentanil

group S

ACTIVE COMPARATOR
Drug: normal saline

Interventions

remifentanilDRUG

General anesthesia is maintained witn sevoflurane and remifentanil.

group SR
normal salineDRUG

General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil

group S

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologist physical status I or II
  • year-old children
  • patients undergoing tonsillectomy and adenoidectomy

You may not qualify if:

  • upper respiratory disease
  • mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

RemifentanilSaline Solution

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 29, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

KR(1)