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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032302
Receipt No. R000036840
Scientific Title The efficasy of dexmedetomidine in preoperaive sleep
Date of disclosure of the study information 2018/04/20
Last modified on 2020/02/05

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Basic information
Public title The efficasy of dexmedetomidine in preoperaive sleep
Acronym The efficasy of dexmedetomidine in preoperaive sleep
Scientific Title The efficasy of dexmedetomidine in preoperaive sleep
Scientific Title:Acronym The efficasy of dexmedetomidine in preoperaive sleep
Region
Japan

Condition
Condition bladder tumor, ureteral stones
Classification by specialty
Urology Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectts of using dexmedetomidine will improve or not the postoperative sleeping disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the presence or absence of the use of sleep-inducing agent
Key secondary outcomes patient's satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 dexmedetomidine
Interventions/Control_2 midazoram
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1)Over 20 years old
2)Patients undergoing urology surgery with spinal anesthesia
3)ASA-PS 1-2
4)Obtained written informed consent
Key exclusion criteria 1 )ASA class >3.
2) Patient with the drug allergy
3) Pregnant woman, breast-feeding woman or possibility of pregnancy
4) constant user of sleep-inducing aganet
5) Judged as unsuitable for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroe
Middle name
Last name Takeda
Organization Tokyo Rinkai Hospital
Division name Department of Anesthesiolgy
Zip code 1340086
Address 1-4-2 Rinkaicho, Edogawa-ku, Tokyo
TEL 03-5605-8811
Email honaka@nms.ac.jp

Public contact
Name of contact person
1st name Hiroe
Middle name
Last name Takeda
Organization Tokyo Rinkai Hospital
Division name Department of Anesthesiolgy
Zip code 1340086
Address 1-4-2 Rinkaicho, Edogawa-ku, Tokyo
TEL 03-5605-8811
Homepage URL
Email honaka@nms.ac.jp

Sponsor
Institute Tokyo Rinkai Hospital
Department of Anesthesiolgy
Institute
Department

Funding Source
Organization Tokyo Rinkai Hospital
Department of Anesthesiolgy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Rinkai Hospital
Address 1-4-2 Rinkaicho, Edogawa-ku, Tokyo
Tel 03-5605-8811
Email honaka@nms.ac.jp

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
2018 Year 04 Month 20 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 50
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 Completed
Date of protocol fixation
2018 Year 04 Month 20 Day
Date of IRB
2018 Year 01 Month 31 Day
Anticipated trial start date
2018 Year 04 Month 20 Day
Last follow-up date
2020 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036840

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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