UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effects of ramelteon on postoperative delirium after elective liver resection
Title of the study (Brief title)	Preventive effects of ramelteon on postoperative delirium after elective liver resection
Region	Japan

Condition
Condition	postoperative delirium after liver resection
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to examine whether ramelteon is effective for the prevention of delirium in elective liver resection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of postoperative delirium
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent liver resection at Nara Medical University (Nara, Japan) from January 2014 to August 2018 were retrieved.
Key exclusion criteria	Patients who could not take water or medicine on POD 1 were excluded.
Target sample size	306

Research contact person
Name of lead principal investigator	Daisuke Hokuto
Organization	Nara Medical University
Division name	Department of surgery
Address	840 shijyo-cho, Kashihara city, Nara, Japan
TEL	0744223051
Email	hokuto@naramed-u.ac.jp

Public contact
Name of contact person	Daisuke Hokuto
Organization	Nara Medical University
Division name	Department of surgery
Address	840 shijyo-cho, Kashihara city, Nara, Japan
TEL	0744223051
Homepage URL
Email	hokuto@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	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	2019 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 09 Month 01 Day
Anticipated trial start date	2019 Year 09 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	Patients who underwent liver resection at Nara Medical University (Nara, Japan) from January 2014 to August 2018 were retrieved. During the period from January 2017 to August 2018, ramelteon was prospectively administered to patients undergoing liver resection (ramelteon group), whereas ramelteon was not administered during the period from January 2014 to December 2016 (control group). The perioperative outcomes of the ramelteon group and the control group were compared.

Management information
Registered date	2019 Year 01 Month 28 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040659