UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054429 |
|---|---|
| Receipt number | R000062168 |
| Scientific Title | Perioperative Lemborexant in arthroplasty surgery: A Feasibility Study |
| Date of disclosure of the study information | 2024/05/18 |
| Last modified on | 2024/08/13 12:20:43 |
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Basic information
Public title
Perioperative Lemborexant in arthroplasty surgery: A Feasibility Study
Acronym
Perioperative Lemborexant in arthroplasty surgery: A Feasibility Study
Scientific Title
Perioperative Lemborexant in arthroplasty surgery: A Feasibility Study
Scientific Title:Acronym
Perioperative Lemborexant in arthroplasty surgery: A Feasibility Study
Region
| Japan |
Condition
Condition
The study will target patients scheduled for knee or hip arthroplasty who have been diagnosed with insomnia and are taking lemborexant. The primary objective will be to determine whether lemborexant can be taken throughout the perioperative period (lemborexant intake rate), with secondary objectives to determine changes in sleep efficiency, the proportion of patients who used sleeping pills and tranquilizers other than lemborexant during the perioperative period, and the degree of postoperative recovery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will target patients scheduled for knee or hip arthroplasty who have been diagnosed with insomnia and are taking lemborexant. The primary objective will be to determine whether lemborexant can be taken throughout the perioperative period (lemborexant intake rate), with secondary objectives to determine changes in sleep efficiency, the proportion of patients who used sleeping pills and tranquilizers other than lemborexant during the perioperative period, and the degree of postoperative recovery.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of taking lemborexant
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study will target patients who are scheduled for knee or hip arthroplasty, have been diagnosed with insomnia, and are taking lemborexant.
Key exclusion criteria
Patients taking hypnotics or antipsychotics other than lemborexant at the time of anesthesiology consultation
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Ida |
| Middle name | |
| Last name | Mitsuru |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8522
Address
Nara Kashihara Shijo-cho 840
TEL
0744298902
nwnh0131@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Ida |
| Middle name | |
| Last name | Mitsuru |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8522
Address
Nara Kashihara Shijo-cho 840
TEL
0744298902
Homepage URL
nwnh0131@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
kashihara shijo 840
Tel
0744298902
nwnh0131@naramed-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062168
