UMIN-CTR Clinical Trial

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