UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for the peripheral circulation of upper limb under spinal anesthesia with or without dexmedetomidine.
Title of the study (Brief title)	Evaluation for the peripheral circulation under spinal anesthesia.
Region	Japan

Condition
Condition	patients undergoing elective surgery under spinal anesthesia.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We estimate peripheral circulation of upper limb under spinal anesthesia by Radical-7. In addition, we estimate effect of dexmedetomidine to peripheral circulation of upper limb under spinal anesthesia.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	perfusion index, pleth variability index
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients who undergo surgery under spinal anesthesia with ASA-PS 1 or 2.
Key exclusion criteria	Age<20, pregnant, patients who undergo surgery using Tourniquet.
Target sample size	40

Research contact person
Name of lead principal investigator	Kenichiro Koda
Organization	Toho University Sakura Medical Center
Division name	Department of Anesthesiology
Address	564-1, Simoshizu, Sakura-shi, Chiba
TEL	043-462-8811
Email	kenich-kou@sakura.med.toho-u.ac.jp

Public contact
Name of contact person	Kenichiro Koda
Organization	Toho University Sakura Medical Center
Division name	Department of Anesthesiology
Address	564-1, Simoshizu, Sakura-shi, Chiba
TEL	043-462-8811
Homepage URL
Email	kenich-kou@sakura.med.toho-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Toho University Sakura Medical Center
Institute
Department

Funding Source
Organization	Toho University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東邦大学医療センター佐倉病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 07 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 15 Day
Anticipated trial start date	2016 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patients are recruited if they undergo surgery with spinal anesthesia in our hospital from Aug 8 2016 and are matched with the criteria. We measure PI and PVI under spinal anesthesia. If patients want to sleep during surgery, we put them under sedation with dexmedetomidine and measure PI and PVI. This is observational study and does not involve any intervention. Twenty patients will be recruited in each group(no sedation group, dexmedetomidine group).

Management information
Registered date	2016 Year 08 Month 05 Day
Last modified on	2016 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027087