UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024996 |
|---|---|
| Receipt number | R000020763 |
| Scientific Title | The effect of dexmedetomidine and midazoram for analgesic period of spinal anesthesia |
| Date of disclosure of the study information | 2016/11/25 |
| Last modified on | 2019/06/06 10:30:30 |
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Basic information
Public title
The effect of dexmedetomidine and midazoram for analgesic period of spinal anesthesia
Acronym
The effects of continuous infusion of dexmedetomidine and midazolam on the duration of blockade after spinal anesthesia.
Scientific Title
The effect of dexmedetomidine and midazoram for analgesic period of spinal anesthesia
Scientific Title:Acronym
The effects of continuous infusion of dexmedetomidine and midazolam on the duration of blockade after spinal anesthesia.
Region
| Japan |
Condition
Condition
Disease under spinal anesthesia is selected
Classification by specialty
| Gastrointestinal surgery | Obstetrics and Gynecology | Orthopedics |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the spinal anesthesia analgesic duration impact on the dexmedetomidine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
duration of effect of spinal subarachnoid anesthesia
Key secondary outcomes
sedation level in anesthesia, blood pressure, heart rate, transcutaneous oxygen saturation, BIS (EEG)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To enforce the spinal puncture. Local anesthetics to be used as a high specific gravity bupivacaine 13mg. Anesthetic effect, check the anesthesia high every 5 minutes after a high specific gravity bupivacaine administration, is carried out to check every 15 minutes after the anesthesia level was fixed. The goal anesthesia sales and Th10 ~ Th4. Effect confirmation of spinal subarachnoid anesthesia is performed analgesia by cold sensation loss and pin prick by the ice pack, and Omotte confirmation of movement disappearance.
Interventions/Control_2
Measuring the time of up to a certain recovery from the spinal subarachnoid anesthesia. Cold sensation disappeared area every 15 minutes and the time until the analgesia area to 2 segmental recovery, the motor nerve blocking Bromage scale to measure the time until recovery to 1.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 ASA PS class1-2
2 under 20 years of age or 80 years of age
3 have obtained the written consent
Key exclusion criteria
1 ASA class3-6
2 do not wish to sedation during surgery
3 BMI30 more patient
4 emergency surgery
5 during pregnancy there is a possibility you are breast-feeding or during pregnancy
6 other research investigator or sharing doctor has determined to be inappropriate as a target
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suzuki Toshiyasu |
Organization
Tokai Univ. School of medicine
Division name
Anesthesia department
Zip code
Address
143 Shimokasuya isehara city kanagawa Japan
TEL
0463-93-1121
suzuki3@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Watanabe |
Organization
Tokai Univ. School of medicine
Division name
Anesthesia department
Zip code
Address
143 Shimokasuya isehara city kanagawa Japan
TEL
0463-93-1121
Homepage URL
9j236559@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai Univ. School of medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
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
東海大学医学部付属大磯病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020763
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