UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000042070
Receipt number	R000047656
Scientific Title	Preventive effects of lemborexant on postoperative delirium in patients with proximal femur fracture surgery and insomnia in the perioperative period: a double-blind, randomized, non-inferiority trial of lemborexant versus ramelteon
Date of disclosure of the study information	2020/10/12
Last modified on	2022/04/04 10:05:01

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Basic information

Public title

Preventive effects of lemborexant on postoperative delirium in patients with proximal femur fracture surgery and insomnia in the perioperative period: a double-blind, randomized, non-inferiority trial of lemborexant versus ramelteon

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Postoperative delirium

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Comparison of lemborexant with ramelteon with respect to the incidence of postoperative delirium in patients with proximal femur fracture surgery and insomnia in the perioperative period

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Assessment

Primary outcomes

Incidence of postoperative delirium

Key secondary outcomes

(1) Severity of delirium: DRS-R-98 (Trzepacz PT 1998)
(2) Length of hospital stay
(3) Sleep parameters
3-1. Time to sleep onset (TSO) and sleep onset time
3-2. Number of awakenings
3-3. Waking up too early
3-4. Total sleep time (TST)
(4) Incidence of at least one adverse event
(5) Incidence of individual adverse events
(6) Incidence of serious adverse events
(7) Death
(8) Incidence of benzodiazepine withdrawal syndrome
(9) All-cause discontinuation rate
(10) Discontinuation rate due to adverse events

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Lemborexant 5 mg will be orally administered once daily before bedtime.

(1) If a patient agrees to participate in our study preoperatively:
The primary outcome of our study (incidence of postoperative delirium) will be observed for 7 days from the date of surgery.
The patient will receive lemborexant from the preoperative day after providing informed consent.
If a patient develops delirium in the time between the intervention start date and pre-surgery, the patient will be excluded from our analysis.

(2) If a patient agrees to participate in our study on the day of surgery:
The primary outcome of our study (incidence of postoperative delirium) will be observed for 7 days from the day of surgery.
The patient will receive lemborexant from the day of surgery after providing informed consent.

(3) If a patient agrees to participate in our study postoperatively:
The primary outcome of our study (incidence of postoperative delirium) will be observed for 7 days from the administration start date.
The patient will receive lemborexant from the postoperative day after providing informed consent.
If a patient develops delirium in the time between post-surgery and the intervention start date, the patient will be excluded from our analysis.

Interventions/Control_2

Ramelteon 8 mg will be orally administered once daily before bedtime.

(1) If a patient agrees to participate in our study preoperatively:
The primary outcome of our study (incidence of postoperative delirium) will be observed for 7 days from the date of surgery.
The patient will receive ramelteon from the preoperative day after providing informed consent.
If a patient develops delirium in the time between the intervention start date and pre-surgery, the patient will be excluded from our analysis.

(2) If a patient agrees to participate in our study on the day of surgery:
The primary outcome of our study (incidence of postoperative delirium) will be observed for 7 days from the day of surgery.
The patient will receive ramelteon from the day of surgery after providing informed consent.

(3) If a patient agrees to participate in our study postoperatively:
The primary outcome of our study (incidence of postoperative delirium) will be observed for 7 days from the administration start date.
The patient will receive ramelteon from the postoperative day after providing informed consent.
If a patient develops delirium in the time between post-surgery and the intervention start date, the patient will be excluded from our analysis.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing proximal femur fracture surgery and experiencing insomnia
Patients capable of giving voluntary written informed consent
Male and female patients aged 65 years and above

The patients are diagnosed with insomnia if sleep disturbance (difficulty falling asleep, awakening halfway, awakening early in the morning, etc.) and associated daytime symptoms (fatigue or malaise, daytime sleepiness, decreased attention/concentration/memory, etc.) are present at least three days a week (ICD11/DSM-5/ICSD-3). Additionally, patients who were already on sleeping pills at the time of obtaining informed consent are also diagnosed with insomnia.

Key exclusion criteria

Patients taking CYP1A2 inhibitors (quinolone antibacterial drug, fluvoxamine), CYP3A4 inhibitors (itraconazole, ketraconazole, fluconazole, verapamil, macrolide antibiotics), CYP3A4 inducers (phenytoin, rifampicin), and central nervous system depressants (barbituric acid derivatives, phenothiazine derivatives)
Patients taking lemborexant, ramelteon
Patients who already have impaired consciousness
Patients with serious physical illness
Patients with a history of hypersensitivity to the components of lemborexant or ramelteon
Others: patients judged to be inappropriate by the principal investigator or coordinator

Target sample size

198

Research contact person

Name of lead principal investigator

1st name Kenji

Middle name

Last name Sakuma

Organization

Fujita Health University School of Medicine

Division name

Department of Psychiatry

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-9250

Email

sakuma44@fujita-hu.ac.jp

Public contact

Name of contact person

1st name Kenji

Middle name

Last name Sakuma

Organization

Fujita Health University School of Medicine

Division name

Department of Psychiatry

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-9250

Homepage URL

Email

sakuma44@fujita-hu.ac.jp

Sponsor or person

Institute

Fujita Health University School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Fujita Health University School of Medicine

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

藤田医科大学病院

Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 12 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 07 Month 13 Day

Date of IRB

2020 Year 09 Month 24 Day

Anticipated trial start date

2020 Year 10 Month 12 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2020 Year 10 Month 10 Day

Last modified on

2022 Year 04 Month 04 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047656

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name