UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028436 |
|---|---|
| Receipt number | R000032553 |
| Scientific Title | The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial |
| Date of disclosure of the study information | 2017/07/29 |
| Last modified on | 2024/02/05 12:50:51 |
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Basic information
Public title
The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Acronym
The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Scientific Title
The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Scientific Title:Acronym
The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Geriatrics | Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients take 8 mg ramelteon for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
Interventions/Control_2
Patients take matching lactose for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
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
American Society of Anesthesiologists physical status 1,2,or 3 and scheduled to undergo general surgery, urological surgery, vascular surgery, or chest surgery under general anesthesia.
Key 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
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ogura |
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name
Department of Anesthesiology
Zip code
1730015
Address
35-2 Sakaecho Itabashi-ku, Tokyo
TEL
03-3964-1141
ogura@tmghig.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Mariko |
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name
Department of Anesthesiology
Zip code
1730015
Address
35-2 Sakaecho Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
mariko2390@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Address
35-2 Sakaecho Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
東京都健康長寿医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/re/reports/file-download/19393
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jagp.2023.07.011
Number of participants that the trial has enrolled
103
Results
The stratified log rank test showed no significant difference between ramelteon and placebo to prevent postoperative delirium in the elderly undergoing abdominal or thoracic surgery ( p = 0.596 ). The findings of this randomized double-blind placebo-controlled trial do not support the effect of ramelteon to prevent postoperative delirium.
Results date posted
| 2024 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
For all enrolled ( n = 103 ) and eligible ( n = 103 ) patients, the mean age was 76.82 years (SD 6.44 ), the median age was 76 years (minimum-maximum 65-94 years), and there were 54 men and 49 women. General anaesthesia was administered by inhalation anaesthesia in 77 patients or by complete intravenous anaesthesia in 26 patients. According to the American Society of Anesthesiologist Physical Status (ASA-PS), 2 patients were categorised as ASA-PS1, 69 as PS2, and 32 as PS3. The median Charlson Comorbidity Index was 3 (range 0-12). 14 subjects had an MMSE score of 23 or less, which is suspicious for dementia.
There were two allocation groups: ramelteon ( n = 54) and placebo ( n = 49). The mean age of the two groups was 78.1 years for ramelteon and 75.4 years for placebo, and the proportion of men was 51.9% and 53.1%.
Participant flow
Among 225 patients who met the inclusion and exclusion criteria, 83 patients who did not undergo preoperative delirium assessment were excluded.
Of the remaining 142 patients, 108 (76.1%) patients or their proxies provided informed consent and were enrolled in the study.
Participants were randomly assigned to receive ramelteon (n = 55) or placebo (n = 53).
Twenty-three(41.8%) patients in the ramelteon group and 21(39.6%) patients in the placebo group were lost to follow-up but were included in the survival analysis.
Any deviation was censored upon its occurrence.
Adverse events
There was no intervention related death during the observation period. A total of 84 participants experienced one or more adverse events. Most of them were postoperative sequelae and transient. Five participants were diagnosed with serious adverse events (SAE) ( seizure, respiratory arrest, cerebral infarction, pulmonary leakage requiring reoperation, thromboembolism, and ileus ). All of the SAEs were unrelated to the trial procedures.
Outcome measures
Postoperative delirium occurred in 7 (13%) participants who received ramelteon ( n = 54 ) vs in 4 (8.2%) who received placebo ( n = 49 ).
The stratified log-rank test showed no significant difference between ramelteon and placebo to prevent postoperative delirium( p = 0.596 ).
The Cox hazard ratio of ramelteon compared to placebo was 1.398 with 95% CI of 0.403 - 4.848 ( p = 0.597 ).
The Cox hazard ratio adjusted for age and previous delirium was 0.884 with 95% CI of 0.197 - 3.967 ( p = 0.872 ).
The max Memorial Delirium Assessment Scale (MDAS) (mean, SD) in the ramelteon group with incidence of postoperative delirium was 10.9, 4.7, while the one in the placebo group was 11.8, 4.8 in the placebo group.
Days to develop postoperative delirium (mean, SD) in the ramelteon group with incidence of delirium was 0.9, 1.1, while the one in the placebo group was 0.0, 0.0 in the placebo group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 29 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032553
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