UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia
Title of the study (Brief title)	the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia
Region	Japan

Condition
Condition	Patients whom scheduled surgery in general, obsterics and gynecology, urology, orthopedics and plastic surgery
Classification by specialty	Surgery in general Obsterics and gynecology Orthopedics Urology Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is difficult for anesthesiologists whom are not accustomed to using dexmedetomidine to determine the dose during an operation. we investigated the optimal dose by evaluating respiratory rate and sedation degree for sedation under local anesthesia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change of hemodynamics
Key secondary outcomes	the change of respiratory rate, bispectral index and saturation

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ASA performance status I or II whom were scheduled to undergo surgery in general, obstetrics and gynecological surgery, urological surgery, orthopedics surgery, dermatological surgery and plastic surgery under local anesthesia.
Key exclusion criteria	Patients whom were unconscious or refused participation of the study
Target sample size	120

Research contact person
Name of lead principal investigator	Mitsutaka Edanaga
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	edanaka@sapmed.ac.jp

Public contact
Name of contact person	Hiroshi Takeda
Organization	Sapporo Medical University School of Medicine
Division name	Hospital Division
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	hiroshi.takeda@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 17 Day
Anticipated trial start date	2013 Year 09 Month 06 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	intervention study

Management information
Registered date	2015 Year 04 Month 27 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020010