UMIN-CTR Clinical Trial

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042070
Receipt No. 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 (Ver. 3)

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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 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Postoperative delirium
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
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
Institute Fujita Health University School of Medicine
Institute
Department

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047656