臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 12, 2018
Last modified on	June. 17, 2021
Trial ID	jRCTs031180054

Scientific Title	The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly : a double blind, randomized, placebo controlled trial (The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly : RCT)
Public Title	The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly : RCT (The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly : RCT)

Contact for Scientific Queries	Name	Ogura Makoto
	Affiliation	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
	Address	35-2 Sakaecho Itabashi-ku, Tokyo
	Telephone	+81-3-3964-1141
	E-mail	ogura@tmghig.jp
Contact for Public Queries	Name	Kinouchi Mariko
	Affiliation	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
	Address	35-2 Sakaecho Itabashi-ku, Tokyo
	Telephone	+81-3-3964-1141
	E-mail	mariko2390@yahoo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 01, 2017
Actual date of first enrollment		Sept. 19, 2017
Target sample size		108
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	American Society of Anesthesiologists physical status 1,2,or 3 and scheduled to undergo general surgery, urological surgery, vascular surgery, or thoracic surgery under general anesthesia
	Exclusion Criteria	Patients who are delirious on registry Patients who are currently taking ramelteon Patients who have a previous adverse reaction to ramelteon Patients who take medicine contraindicated to be coadministered with ramelteon Patients with lactose intolerance Patients who are considered non per os on postoperative day 1 Patients who are considered to be discharged within postoperative day 6 Patients who have a score less than or equal to 10 on the Mini Mental State Examination Patients who have severe hepatic damage Patients with known Dementia with Lewy bodies
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		postoperative delirium
Intervention(s)		Intervention: Patients take 8 mg ramelteon for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1. Control: Patients take matching lactose for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The difference in the incidence of delirium as determined by Diagnostic and Statistical Manual of Mental Disorders, version 5 criteria between the placebo and ramelteon groups from postoperative day 0 to 6.
Secondary Outcome(s)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Secondary Sponsor	Not applicable

Name of Certified Review Board	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology Clinical Research Review Board
Address	35-2 Sakaecho Itabashi-ku, Tokyo, Tokyo
Telephone	+81-3-3964-1141
E-Mail	rinsyoushiken@tmghig.jp
Approval Status	Approval
Date of approval	Oct. 12, 2018

Plan to share IPD	No
Plan description

Secondary ID(s)	R000032553
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 17, 2021	(this page)	Changes
2	Sept. 19, 2019	Detail	Changes
1	Dec. 12, 2018	Detail

List of change history