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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040722
Receipt No. 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

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Basic information
Public title The usefulness of dual channel elastomeric pump for intravenous patient-controlled analgesia in geriatrics underwent gastrointestinal tumor surgery : a randomized, double-blind, prospective study
Acronym dual channel IV PCA in elderly patients underwent gastrointestinal tract surgery
Scientific Title Efficacy of dual channel IV-PCA in geriatrics underwent gastrointestinal tumor surgery
Scientific Title:Acronym dual channel IV-PCA in geriatrics underwent gastrointestinal tumor surgery
Region
Asia(except Japan)

Condition
Condition Elderly patients above 65 years underwent laparoscopic gastrectomy and colorectal surgery
Classification by specialty
Geriatrics Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of dual channel opioid IV-PCA and single channel opioid control group IV-PCA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Opioid(fentanyl) consumption after surgery dependent on pain score(Verbal numeric rating scale)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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)"
Interventions/Control_2 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)"
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria ASA I-III patients expecting a scheduled laparoscopic gastric or colorectal surgery
Key exclusion criteria 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
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Young Ju
Middle name
Last name Won
Organization Korea University Guro Hospital
Division name Department of Anesthesiology and Pain medicine
Zip code 08308
Address 148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82-2-2626-1437
Email moma2@naver.com

Public contact
Name of contact person
1st name Young Ju
Middle name
Last name Won
Organization Korea University Guro Hospital
Division name Department of Anesthesiology and Pain medicine
Zip code 08308
Address 148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82-2-2626-1437
Homepage URL
Email moma2@naver.com

Sponsor
Institute Korea University Guro Hospital
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Korea

Other related organizations
Co-sponsor Not applicable
Name of secondary funder(s) Not applicable

IRB Contact (For public release)
Organization Korea University Guro Hospital
Address 148, Gurodong-ro, Guro-gu, Seoul, Korea
Tel 82-2-2626-1632
Email eirbadmin@kumc.or.kr

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 05 Month 06 Day
Anticipated trial start date
2020 Year 06 Month 11 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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