UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032302 |
|---|---|
| Receipt number | 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 11:13:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
honaka@nms.ac.jp
Sponsor or person
Institute
Tokyo Rinkai Hospital
Department of Anesthesiolgy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036840
