UMIN-CTR Clinical Trial

Basic information
Public title	Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Acronym	Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Scientific Title	Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Scientific Title:Acronym	Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Region	Japan

Condition
Condition	Patients undergoing elective surgery under spinal anesthesia.
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the timing of dexmedetomidine administration affect hemodynamic changes in spinal anesthesia.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Blood plessure changes after spinal anesthesia.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention:Start dexmedetomidine administration at the same time as local anesthesia injection.
Interventions/Control_2	Control:Start dexmedetomidine administration at 15 minutes after local anesthesia injection.
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	55 years-old >=
Gender	Male
Key inclusion criteria	Patients with ASA Physical status 1 or 2
Key exclusion criteria	Obesity (BMI>35) Hypertension Patient with a history of cardiac disease. Patient who don't wish to sedation.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Ayana Middle name Last name Kanaya
Organization	Japan Self Defense Force Hospital Yokosuka
Division name	Department of Anesthesiology
Zip code	2370071
Address	1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL	046-823-0270
Email	sweetberryst@gmail.com

Public contact
Name of contact person	1st name Takahiro Middle name Last name Ogura
Organization	Japan Self Defense Force Hospital Yokosuka
Division name	Department of Anesthesiology
Zip code	2370071
Address	1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL	046-823-0270
Homepage URL
Email	dr21032@ndmc.ac.jp

Sponsor
Institute	Japan Self Defense Force Hospital Yokosuka
Institute
Department

Funding Source
Organization	None
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	Japan self defense force Hospital Yokosuka
Address	1766-1 Tauramiatocho Yokosuka Kanagawa
Tel	046-823-0270
Email	yhl-hsoumu@inet.msdf.mod.go.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	自衛隊横須賀病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://iss.ndl.go.jp/books/R000000004-I030530794-00
Number of participants that the trial has enrolled	20
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	2013 Year 12 Month 05 Day
Date of IRB	2013 Year 12 Month 26 Day
Anticipated trial start date	2014 Year 01 Month 07 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 07 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014923