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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024996
Receipt No. 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

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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 Obsterics 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
Email 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
Email 9j236559@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai Univ. School of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020763

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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