NCT01517438

Brief Summary

ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or adenoidectomy in children

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

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

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

January 17, 2012

Last Update Submit

January 20, 2012

Conditions

Agitation

Keywords

agitation, desflurane, children

Outcome Measures

Primary Outcomes (1)

  • agitation score

    agitation score

    30 minutes after postoperatuib

Interventions

agitationBEHAVIORAL

agitation score after desflurane anesthesia

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • tonsillectomy or adenoidectomy

You may not qualify if:

  • development delay,
  • CNS abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 25, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 25, 2012

Record last verified: 2012-01