Unique ID issued by UMIN | UMIN000039702 |
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Receipt number | R000045281 |
Scientific Title | The usefulness of dual channel elastomeric pump for intravenous patient-controlled analgesia in geriatrics: a randomized, double-blind, prospective study |
Date of disclosure of the study information | 2020/03/05 |
Last modified on | 2021/03/05 19:33:29 |
The usefulness of dual channel elastomeric pump for intravenous patient-controlled analgesia in geriatrics: a randomized, double-blind, prospective study
Efficacy of dual channel IV-PCA in geriatrics
The usefulness of dual channel elastomeric pump for intravenous patient-controlled analgesia in geriatrics: a randomized, double-blind, prospective study
Efficacy of dual channel IV-PCA in geriatrics
Asia(except Japan) |
Elderly patients above 65 years undergoing orthopedic surgery
Geriatrics | Orthopedics |
Others
NO
Comparison of dual channel IV-PCA and single channel + placebo IV-PCA
Efficacy
Not applicable
Opioid(fentanyl) consumption after surgery (post-op 6, 12, 24, 36, 48 hours)
Pain score(Verbal numeric rating scale)
rescue analgesic (ketorolac)
patient satisfaction
recovery scores including RASS, CAM-ICU and PARS
adverse events including PONV
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Device,equipment |
Interventions:
Fentanyl based PCA in both "Basal and bolus channel (constant flow channel; fentanyl 13 ug/kg + ramosetron 0.4mg, total 100ml, 2ml/hr)" and "Selector channel (adjustable flow channel;fentanyl 7 ug/kg + ramosetron 0.2mg, total 50ml, 1(0-2)ml/hr)"
Control:
Fentanyl based PCA in "Basal and bolus channel (constant flow channel; fentanyl 20 ug/kg + ramosetron 0.6mg, total 100ml, 2ml/hr)" and Placebo in "Selector channel (adjustable flow channel; normal saline 50ml, 1(0-2)ml/hr)"
65 | years-old | <= |
79 | years-old | >= |
Male and Female
ASA I-III patients expecting a scheduled orthopedic surgery
BMI at or above 35, drug abuse, allergy history in fentanyl and ramosetron, dementia, psychiatric disease, communication problem, severe chronic pain, and incapable of decision making
90
1st name | Young Sung |
Middle name | |
Last name | Kim |
Korea University Guro Hospital
Department of Anesthesiology and Pain medicine
08308
148, Gurodong-ro, Guro-gu, Seoul, Korea
82-2-2626-1437
stelios@naver.com
1st name | Young Sung |
Middle name | |
Last name | Kim |
Korea University Guro Hospital
Department of Anesthesiology and Pain medicine
08308
148, Gurodong-ro, Guro-gu, Seoul, Korea
82-2-2626-1437
https://guro.kumc.or.kr
stelios@naver.com
Korea University Guro Hospital
Not applicable
Self funding
Korea
Not applicable
Not applicable
Korea University Guro Hospital
148, Gurodong-ro, Guro-gu, Seoul, Korea
82-2-2626-1632
eirbadmin@kumc.or.kr
NO
Korea University Guro Hospital(Seoul,Korea)
2020 | Year | 03 | Month | 05 | Day |
Unpublished
87
Completed
2019 | Year | 09 | Month | 30 | Day |
2019 | Year | 10 | Month | 01 | Day |
2019 | Year | 10 | Month | 02 | Day |
2020 | Year | 05 | Month | 20 | Day |
2020 | Year | 05 | Month | 30 | Day |
2020 | Year | 05 | Month | 30 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 03 | Month | 05 | Day |
2021 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045281
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2021/03/05 | PCA_OLD_DATA.xlsx |