Clinical Trials Logo
  1. Home
  2. Agitation
  3. NCT01374737
  4. Details
NCT01374737 Clinical Trial

ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

Agitation Clinical Trial

Official title:
ED50 of Dexmedetomidine for Reduction of Emergence Agitation Incidence Undergoing Tonsillectomy or Adenoidectomy in Desflurane Anesthesia Following Sevoflurane Induction in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01374737
Other study ID # KHS_1
Secondary ID
Status Recruiting
Phase Phase 4
First received June 9, 2011
Last updated June 15, 2011
Start date June 2011
Est. completion date February 2012

Study information
Verified date June 2011
Source Seoul National University Hospital
Contact Hee-Soo Kim, M.D., PhD
Phone 82220723659
Email dami0605@snu.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

Description:

To investigate ED50, Dixon's up and down method will be used.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date February 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria:

- tonsillectomy or adenoidectomy

Exclusion Criteria:

- recent URI

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine, 0.1ug/kg up or down

Locations
Country Name City State
Korea, Republic of SNUH Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary agitation 30 minutes No
Secondary pain 30 minutes No
See also
  Status Clinical Trial Phase
Completed NCT02525991 - Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting Phase 4
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Completed NCT01976754 - Safety Study of Dexmedetomidine in Septic Patients N/A
Completed NCT01217541 - Collaboration Between Department of Old Age Psychiatry and Nursing Homes N/A
Withdrawn NCT00786318 - Ziprasidone vs Standard Therapy for Agitated Patients in the ED Phase 4
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
Not yet recruiting NCT05522647 - Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
Recruiting NCT02590744 - Effects of Preoperative Using of Eye Patches on Prevention of Emergence Agitation After Cataract Surgery N/A
Recruiting NCT02164773 - Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation. Phase 4
Completed NCT01524367 - Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery Phase 4
Completed NCT01501123 - Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient N/A
Completed NCT01021696 - Pain in Patients With Dementia and Behavioural Disturbances Phase 2/Phase 3
Recruiting NCT05397639 - Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type Phase 3
Terminated NCT03044249 - A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression Phase 2
Completed NCT05165914 - Midazolam Effect on Agitation Postnasal Surgery N/A
Completed NCT04010305 - Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia Phase 1
Completed NCT02720705 - Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children Phase 2/Phase 3
Completed NCT02428283 - Scalp Nerve Block on Emergence Agitation Phase 4
Completed NCT00457366 - A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room Phase 4
Terminated NCT00315900 - Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia Phase 3