UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052428 |
|---|---|
| Receipt number | R000059767 |
| Scientific Title | the effect of anesthetics on postoperative delirium in hip fracture surgery in elderly patients -comparison of remimazolam and desflurane- |
| Date of disclosure of the study information | 2023/10/05 |
| Last modified on | 2024/10/11 17:20:36 |
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Basic information
Public title
the effect of anesthetics on postoperative delirium in hip fracture surgery in elderly patients
-comparison of remimazolam and desflurane-
Acronym
the effect of anesthetics on postoperative delirium in hip fracture surgery in elderly patients
-comparison of remimazolam and desflurane-
Scientific Title
the effect of anesthetics on postoperative delirium in hip fracture surgery in elderly patients
-comparison of remimazolam and desflurane-
Scientific Title:Acronym
the effect of anesthetics on postoperative delirium in hip fracture surgery in elderly patients
-comparison of remimazolam and desflurane-
Region
| Japan |
Condition
Condition
hip fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the use of remimazolam is associated with an increased or decreased incidence of postoperative delirium compared with desflurane in elderly patients undergoing surgery for hip fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of delirium from surgery to postoperative day 5
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
remimazolam
Interventions/Control_2
desflurane
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 following criteria are in order to meet eligibility requirements for the current study.
1)Patients undergoing surgery for hip fracture during the research period
2)Patients over 65 years old
Key exclusion criteria
Patients who meet any of the following conditions will not be included in this study:
1)Patients with a history of hypersensitivity to remimazolam or desflurane
2)Patients with acute obstructive glaucoma
3)Patients with myasthenia gravis
4)Patients in shock, coma, or acute alcohol poisoning
5)Patients with a history of malignant hyperthermia or a history of malignant hyperthermia in a blood relative
6)Patients who are unable to communicate due to severe mental illness, language impairment, visual impairment, etc.
7)Patients who developed new cerebrovascular disease during the period
8)Patients requiring intensive care management
9)Patients who died within 5 days after surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | RUMI |
| Middle name | |
| Last name | SETO |
Organization
Yamaguchi University hospital
Division name
Anesthesiology
Zip code
74508522
Address
1-1-1 minamikogushi,ube-shi, yamaguchi
TEL
0836222291
seto1028@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | rumi |
| Middle name | |
| Last name | seto |
Organization
Yamaguchi University hospital
Division name
Anesthesiology
Zip code
74508522
Address
1-1-1 minamikogushi,ube-shi, yamaguchi
TEL
0836222291
Homepage URL
seto1028@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University hospital
Institute
Department
Personal name
rumi seto
Funding Source
Organization
no
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
Japan community health care organization Tokuyama central hospital
Address
1-1 koudachou, syuunan-shi, yamaguchi
Tel
0834284411
kawano-rumi@tokuyama.jcho.go.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
| 2023 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
65
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
Main results already published
Date of protocol fixation
| 2023 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059767
