UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques
Title of the study (Brief title)	The Effects of Dexmedetomidine on Preventing Delirium in Elderly Patients with Different Anesthetic Techniques
Region	Asia(except Japan)

Condition
Condition	Perioperative administration of dexmedetomindine prevent the incidence of delirium in elderly patiens undergoing major surgeries
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	demedetomidine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence of postoperative delirium
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	dexmedetomidine TIVA/normal saline TIVA
Interventions/Control_2	dexmedetomidine Intravenous inhalational anesthesia /normal saline Intravenous inhalational anesthesia
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	65 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	undergoing general anesthesia for gastrointestinal surgery
Key exclusion criteria	known or suspected allergy to a2-adrenergic agonist
Target sample size	120

Research contact person
Name of lead principal investigator	GUOLIN WANG
Organization	TianJin Medical University General Hospital
Division name	department of anesthesiology
Address	Anshan No. 154,Heping,Tianjin,China
TEL	022-60362288
Email	Wgl202@qq.com

Public contact
Name of contact person	GUOLIN WANG
Organization	TianJin Medical University General Hospital
Division name	department of anesthesiology
Address	Anshan No. 154,Heping,Tianjin,China
TEL	022-60362288
Homepage URL
Email	Wgl202@qq.com

Sponsor
Institute	TianJin Medical University General Hospital
Institute
Department

Funding Source
Organization	TianJin Medical University General Hospital
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 30 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	2017 Year 08 Month 08 Day
Last modified on	2017 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032696