UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013468 |
|---|---|
| Receipt number | R000015721 |
| Scientific Title | Randomized, Controlled, Trial;Effect of dexmedetomidine for inguinal hernia repair with local anesthesia |
| Date of disclosure of the study information | 2014/03/25 |
| Last modified on | 2019/03/26 21:34:04 |
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Basic information
Public title
Randomized, Controlled, Trial;Effect of dexmedetomidine for inguinal hernia repair with local anesthesia
Acronym
Randomized, Controlled, Trial;Effect of dexmedetomidine for inguinal hernia repair with local anesthesia
Scientific Title
Randomized, Controlled, Trial;Effect of dexmedetomidine for inguinal hernia repair with local anesthesia
Scientific Title:Acronym
Randomized, Controlled, Trial;Effect of dexmedetomidine for inguinal hernia repair with local anesthesia
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of dexmedetomidine during inguinal hernia repair with local anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of adverse events
Key secondary outcomes
patients satisfaction.
operator satisfaction.
operation time.
Observer Assessment of Alertness and Sedation Scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of dexmedetomidine
Interventions/Control_2
Intravenous administration of midazolam
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients planned to undergo unilateral inguinal hernia repair by tension free technique with local anesthesia.
Consent to participate in this study.
Patients adaptable for dexmedetomidine and midazolam.
Key exclusion criteria
serious systemic disease.
Patients with mental/neurologic disorder influence mental state.
Femoral hernia.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehito Kato |
Organization
Toyohashi Municipal Hospital
Division name
general surgery
Zip code
Address
50 Hakken nishi, Aotakecho, Toyohashi, Aichi
TEL
0532-33-6111
kato-takehito@toyohashi-mh.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshisada Aiba |
Organization
Toyohashi Municipal Hospital
Division name
general surgery
Zip code
Address
50 Hakken nishi, Aotakecho, Toyohashi, Aichi
TEL
0532-33-6111
Homepage URL
toshisada5445@hotmail.co.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
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
| 2014 | Year | 03 | Month | 25 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015721
