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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01517438
Other study ID # ramosetron
Secondary ID
Status Completed
Phase N/A
First received January 17, 2012
Last updated January 20, 2012
Start date March 2011
Est. completion date December 2011

Study information

Verified date January 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 15 Years
Eligibility Inclusion Criteria:

- tonsillectomy or adenoidectomy

Exclusion Criteria:

- development delay,

- CNS abnormality

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
agitation
agitation score after desflurane anesthesia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary agitation score agitation score 30 minutes after postoperatuib No
See also
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Not yet recruiting NCT05974527 - Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department Phase 4
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Terminated NCT00315900 - Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia Phase 3