UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation
Title of the study (Brief title)	the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation
Region	Japan

Condition
Condition	the patients proposed operation under local anesthesia
Classification by specialty	Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the degree of sedation by middle dose of dexmedetomidine with minimum dose of it during using Sedline which is the monitoring for evaluation of the degree of sedation
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change of the degree of sedation, respiratory rate, oxygenation, systolic blood pressure and heart rate at every 15 minutes, and RASS score at the operation finished
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	low dose of dexmedetomidine group: 6 microgram/kg /hr dexmedetomidine was administered over a period of 10 minutes as a loading dose, and then maintenance infusion (0.2 microgram/kg/hr) was started.
Interventions/Control_2	middle dose of dexmedetomidine group: 6 microgram/kg /hr dexmedetomidine was administered over a period of 10 minutes as a loading dose, and then maintenance infusion (0.4 microgram/kg/hr) was started.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	the patients which has ASA PS I or II and proposed operation under local anesthesia
Key exclusion criteria	the patients who has difficulty in mutual understanding , has difficulty to get cooperation, has cardiovascular or respiratory or neurological complication
Target sample size	50

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	011-688-9663
Email	edanaka@sapmed.ac.jp

Public contact
Name of contact person	Kouji Hamaya
Organization	Sapporo Medical University School of Medicine
Division name	Hospital section
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	ko-hamaya-923@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	2016 Year 03 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 04 Month 01 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

Management information
Registered date	2016 Year 03 Month 30 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025018