UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028566 |
|---|---|
| Receipt number | R000032696 |
| Scientific Title | The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques |
| Date of disclosure of the study information | 2018/01/30 |
| Last modified on | 2017/09/04 00:40:03 |
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Basic information
Public title
The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques
Acronym
The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques
Scientific Title
The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques
Scientific Title:Acronym
The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques
Region
| Asia(except Japan) |
Condition
Condition
Perioperative administration of dexmedetomindine prevent the incidence of delirium in elderly patiens undergoing major surgeries
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
demedetomidine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of postoperative delirium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
dexmedetomidine TIVA/normal saline TIVA
Interventions/Control_2
dexmedetomidine Intravenous inhalational anesthesia /normal saline Intravenous inhalational anesthesia
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
undergoing general anesthesia for gastrointestinal surgery
Key exclusion criteria
known or suspected allergy to a2-adrenergic agonist
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | GUOLIN WANG |
Organization
TianJin Medical University General Hospital
Division name
department of anesthesiology
Zip code
Address
Anshan No. 154,Heping,Tianjin,China
TEL
022-60362288
Wgl202@qq.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | GUOLIN WANG |
Organization
TianJin Medical University General Hospital
Division name
department of anesthesiology
Zip code
Address
Anshan No. 154,Heping,Tianjin,China
TEL
022-60362288
Homepage URL
Wgl202@qq.com
Sponsor or person
Institute
TianJin Medical University General Hospital
Institute
Department
Personal name
Funding Source
Organization
TianJin Medical University General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 30 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2017 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032696
