NCT01691001

Brief Summary

Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 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, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

September 12, 2012

Last Update Submit

September 18, 2012

Conditions

Ambulation Difficulty

Outcome Measures

Primary Outcomes (1)

  • the reduction rate of ET-sevo in achieving BIS scores from 45-50

    2 hour(during whole operation period)

Study Arms (2)

dexmedetomidine

EXPERIMENTAL
Drug: Dexmedetomidine

placebo group

PLACEBO COMPARATOR

normal saline

Drug: normal saline

Interventions

DexmedetomidineDRUG

dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.

dexmedetomidine
normal salineDRUG
placebo group

Eligibility Criteria

Age1 Year - 5 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA class I
  • obtaining written informed consent from the parents
  • aged 1-5 years, and weighing \<20 kg who were undergoing ambulatory hernioplasty or orchiopexy

You may not qualify if:

  • mental retardation
  • developmental delays
  • neurological or psychiatric illnesses
  • coagulation disorder
  • spinal anomalies
  • bilateral procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Mobility Limitation

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 24, 2012

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

KR(1)