UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044416 |
|---|---|
| Receipt number | R000050736 |
| Scientific Title | A retrospective analysis of postoperative delirium after desflurane anesthesia |
| Date of disclosure of the study information | 2021/06/03 |
| Last modified on | 2021/06/03 19:07:35 |
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Basic information
Public title
A retrospective analysis of postoperative delirium after desflurane anesthesia
Acronym
Postoperative delirium after desflurane anesthesia
Scientific Title
A retrospective analysis of postoperative delirium after desflurane anesthesia
Scientific Title:Acronym
Postoperative delirium after desflurane anesthesia
Region
| Japan |
Condition
Condition
Not specified
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of delirium and adverse events in the early postoperative period in patients managed under desflurane anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative delirium between groups receiving desflurane and those not receiving desflurane
Key secondary outcomes
The incidence of delirium in the elderly group (65 years and older) and the non-elderly group (under 65 years)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria will be patients who meet the following conditions
(1) Patients who underwent surgery under general anesthesia at Tohoku University Hospital in 2020
(2) Patients who are admitted to the intensive care unit (ICU/HCU) after surgery
(3) Adult patients aged 20 years or older
(4) Gender is not required.
Key exclusion criteria
Patients who were sedated or on a ventilator when they entered the intensive care unit. Patients whose consent cannot be obtained from the patient.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | KOTOE |
| Middle name | |
| Last name | KAMATA |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL
+81-22-717-7321
kotoe.kamata.c3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | KOTOE |
| Middle name | |
| Last name | KAMATA |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL
+81-22-717-7321
Homepage URL
kotoe.kamata.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
SHISEIKAI ASSOCIATION
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2021 | Year | 06 | Month | 03 | 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
1041
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | 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
･ The population will consist of critically ill adult patients who underwent surgery under general anesthesia at Tohoku University Hospital in 2020 and were admitted to the intensive care unit (ICU/HCU) after surgery.
･ We will compare the incidence of postoperative delirium in the desflurane group and the non-desflurane group.
･ We will compare the incidence of postoperative delirium in the elderly group and the non-elderly group.
･ The risk factors for the development of postoperative delirium will be investigated by multivariate analysis of patient background, surgical factors (operative time, blood loss), and concomitant anesthesia methods (nerve block, epidural anesthesia).
Management information
Registered date
| 2021 | Year | 06 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050736
