65 Years
85 Years
Male
Benign Prostate Hyperplasia, Bladder Tumor
Trial Information
Inclusion Criteria:
- Elderly patients aged 65~85 years olds undergoing TURB or TURP.
- No contraindication of spinal anesthesia.
- ASA class I and II.
- Patients consented to spinal anesthesia were enrolled.
Exclusion Criteria:
- Patients with hypovolemia, coagulation disorders, local infection at the site of
operation, history of headache, heart diseases, and history of allergy, chronic
alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive
heart failure or arrythmias, and patients who had recently received sedative drugs or
were under antidepressant treatment were not included in the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Observer's Assessment of Alertness/Sedation scale, OAA/S
Outcome Description:
Observer's Assessment of Alertness/Sedation scale, OAA/S 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking 1 Responds only after painful trapezius squeeze 0 No response after painful trapezius squeeze 0 No response after painful trapezius squeeze
Outcome Time Frame:
from 5 min after study drug (dexmedetomidine or placebo) adminstration to the ending point of surgery.
Safety Issue:
No
Authority:
South Korea: Institutional Review Board
Study ID:
4-2011-0927
NCT ID:
NCT01665586
Start Date:
March 2012
Completion Date:
February 2014
Related Keywords:
- Benign Prostate Hyperplasia
- Bladder Tumor
- dexmedetomidine
- sedation in elderly patient
- spinal anesthesia
- Prostatic Hyperplasia
- Urinary Bladder Neoplasms
- Hyperplasia
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