Unique ID issued by UMIN | UMIN000040722 |
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Receipt number | R000046486 |
Scientific Title | Efficacy of dual channel IV-PCA in geriatrics underwent gastrointestinal tumor surgery |
Date of disclosure of the study information | 2020/06/11 |
Last modified on | 2020/06/11 14:53:09 |
The usefulness of dual channel elastomeric pump for intravenous patient-controlled analgesia in geriatrics underwent gastrointestinal tumor surgery : a randomized, double-blind, prospective study
dual channel IV PCA in elderly patients underwent gastrointestinal tract surgery
Efficacy of dual channel IV-PCA in geriatrics underwent gastrointestinal tumor surgery
dual channel IV-PCA in geriatrics underwent gastrointestinal tumor surgery
Asia(except Japan) |
Elderly patients above 65 years underwent laparoscopic gastrectomy and colorectal surgery
Geriatrics | Gastrointestinal surgery |
Malignancy
NO
Comparison of dual channel opioid IV-PCA and single channel opioid control group IV-PCA
Efficacy
Not applicable
Opioid(fentanyl) consumption after surgery dependent on pain score(Verbal numeric rating scale)
recovery scores including RASS, CAM-ICU and PARS
Intestinal motility in post op state(time taken to be gassed out)
adverse events including PONV , patient satisfaction
Interventional
Parallel
Randomized
Individual
Single blind -participants 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 10 ug/kg + ramosetron 0.6mg, total 100ml, 2ml/hr)" and "Selector channel (adjustable flow channel;fentanyl 10 ug/kg + ketorolac 150mg, total 100ml, 2(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; Ketorolac 150mg, 2(0-2)ml/hr)"
65 | years-old | <= |
79 | years-old | >= |
Male and Female
ASA I-III patients expecting a scheduled laparoscopic gastric or colorectal 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 Ju |
Middle name | |
Last name | Won |
Korea University Guro Hospital
Department of Anesthesiology and Pain medicine
08308
148, Gurodong-ro, Guro-gu, Seoul, Korea
82-2-2626-1437
moma2@naver.com
1st name | Young Ju |
Middle name | |
Last name | Won |
Korea University Guro Hospital
Department of Anesthesiology and Pain medicine
08308
148, Gurodong-ro, Guro-gu, Seoul, Korea
82-2-2626-1437
moma2@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
2020 | Year | 06 | Month | 11 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 05 | Month | 01 | Day |
2020 | Year | 05 | Month | 06 | Day |
2020 | Year | 06 | Month | 11 | Day |
2021 | Year | 10 | Month | 31 | Day |
2020 | Year | 06 | Month | 11 | Day |
2020 | Year | 06 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046486
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