UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041316 |
|---|---|
| Receipt number | R000047129 |
| Scientific Title | Effects of general anesthesia with remimazolam besilate and postoperative delirium in elderly patients: a prospective observational study |
| Date of disclosure of the study information | 2020/08/12 |
| Last modified on | 2022/08/06 09:26:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of general anesthesia with remimazolam besilate and postoperative delirium in elderly patients: a prospective observational study
Acronym
Effects of general anesthesia with remimazolam besilate and postoperative delirium in elderly patients: a prospective observational study
Scientific Title
Effects of general anesthesia with remimazolam besilate and postoperative delirium in elderly patients: a prospective observational study
Scientific Title:Acronym
Effects of general anesthesia with remimazolam besilate and postoperative delirium in elderly patients: a prospective observational study
Region
| Japan |
Condition
Condition
Scheduled surgery under general anesthesia
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does general anesthesia with remimazolam besilate affect the delirium that occurs in the postoperative intensive care unit?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of delirium
Key secondary outcomes
Duration of delirium, incidence of pre-delirium according to the Intensive Care Delirium Screening Checklist, post-operative Mini-Mental State Examination score, post-operative CRP level, and BIS level immediately before the onset of delirium.
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
Patients over 65 years of age who are scheduled to be admitted to the ICU after a scheduled operation under general anesthesia
Key exclusion criteria
1. Patients with an MMSE score of less than 24 points preoperatively
2. Patients with psychiatric disorders who are treated with psychotropic drugs
3. Patients in a coma after cardiac arrest resuscitation or due to traumatic brain injury
4. Seizure overload or similar condition
5. Post-neurosurgery or symptoms of intracranial hypertension
6. Patient after cardiopulmonary resuscitation
7. Patients with alcohol withdrawal
8. Patients with hepatic encephalopathy or other conditions that are thought to affect their consciousness before surgery
9. Emergency Surgery
10. Other patients who are deemed by the physician to be exempt
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Aoki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-Ku, Hamamatsu-shi, Shizuoka
TEL
0534352111
ysyaoki27@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Aoki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-Ku
TEL
0534352111
Homepage URL
ysyaoki27@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-Ku
Tel
0534352111
ysyaoki27@gmail.com
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
| 2020 | Year | 08 | 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
200
Results
The proportions of patients who developed delirium within 5 days of surgery were 18/78 (23.1%) in the remimazolam group and 34/122 (27.9%) in the control group.
Results date posted
| 2022 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Because this was an observational study, the backgrounds of the two groups were not aligned, and a propensity score was used to align the backgrounds of the two groups.
Participant flow
All events were followed up until initial discharge.
Adverse events
This is an observational study and no adverse events have occurred that originated from this study.
Outcome measures
The primary endpoint was occurrence of delirium within 5 days postoperatively. Secondary endpoints were occurrence of delirium during ICU stay, occurrence of delirium during hospitalization, duration of delirium, occurrence of subsyndromal delirium during ICU stay, and change in MMSE (preoperative to 2 days postoperative, preoperative to 5 days postoperative).
Plan to share IPD
No sharing of individual case data.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 28 | Day |
Other
Other related information
Delirium will be followed until ICU discharge, with a sample size of 100 remimazolam cases and a target of 100 other anesthetics.
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047129
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
