UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of sedation under mechanical ventilation on postoperative cognitive function and recovery profiles
Title of the study (Brief title)	Sedation and postoperative cognitive function
Region	Japan

Condition
Condition	Postoperative oral and maxillofacial surgical patients
Classification by specialty	Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effects of sedation on postoperative cognitive function
Basic objectives2	Others
Basic objectives -Others	Effects of sedation on postoperative recovery profiles
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Effects of sedation duration on postoperative cognitive function
Key secondary outcomes	Effects of sedation duration on side effects

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	55 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Surgical patients
Key exclusion criteria	Patients with dementia are excluded
Target sample size	20

Research contact person
Name of lead principal investigator	Satoki Inoue
Organization	Nara Medical University
Division name	Division of Intensive Care
Address	840 Shijo-cho Kashihara Nara
TEL	0744-22-3051
Email	seninoue@naramed-u.ac.jp

Public contact
Name of contact person	Satoki Inoue
Organization	Nara Medical University
Division name	Division of Intensive Care
Address	840 Shijo-cho Kashihara Nara
TEL	0744-22-3051
Homepage URL
Email	seninoue@naramed-u.ac.jp

Sponsor
Institute	Department of Anesthesiology Nara Medical University
Institute
Department

Funding Source
Organization	Department of Anesthesiology Nara Medical University
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 11 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2020 Year 09 Month 01 Day
Date of closure to data entry	2020 Year 09 Month 01 Day
Date trial data considered complete	2020 Year 09 Month 01 Day
Date analysis concluded	2020 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Under observation Initially, Neck, throat, and ear surgical patients should have veen enrolled; however, these patients did not need to be sedated. Thus, participants has been changed toonly oral surgical patients.

Management information
Registered date	2015 Year 11 Month 24 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013576