UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041873 |
|---|---|
| Receipt number | R000047799 |
| Scientific Title | Effect of Neuromuscular Reversal by Sugammadex or Pyridostigmine on Post-anesthesia care unit Delirium and Postoperative Delirium after Lower Extremity Surgery under General Anesthesia in Elderly Patients: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2020/09/23 |
| Last modified on | 2022/07/08 10:25:47 |
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Basic information
Public title
Effect of Neuromuscular Reversal by Sugammadex or Pyridostigmine on Post-anesthesia care unit Delirium and Postoperative Delirium after Lower Extremity Surgery under General Anesthesia in Elderly Patients: A Retrospective Cohort Study
Acronym
Suganmmadex versus pyridostygmin on Postoperative Delirium after lower extremity Surgery under General Anesthesia
Scientific Title
Effect of Neuromuscular Reversal by Sugammadex or Pyridostigmine on Post-anesthesia care unit Delirium and Postoperative Delirium after Lower Extremity Surgery under General Anesthesia in Elderly Patients: A Retrospective Cohort Study
Scientific Title:Acronym
Suganmmadex versus pyridostygmin on Postoperative Delirium after lower extremity Surgery under General Anesthesia
Region
| Asia(except Japan) |
Condition
Condition
Elderly patients underwent lower extremity surgery under general anesthesia
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective study aimed to investigate the effect of Suganmmadex versus pyridostygmin (anticholinerase inhibitor) on Post-anesthetic care unit Delirium and Postoperative Delirium in Elderly Patients underwent lower extremity surgery under general anesthesia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of Post-anesthetic care unit Delirium assessed by CAM-ICU
Key secondary outcomes
The incidence of Postoperative 5 day Delirium assessed by CAM-ICU
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
Elderly Patients underwent Lower Extremity Surgery under General Anesthesia
Key exclusion criteria
1) ASA class >3 , 2) under 65 years old, 3) patients with neurological symptoms before surgery (dementia, Parkinson's disease, etc.), 4) patients with hearing and visual impairment, 5) possibility of illiteracy, 6) patients with mental illness, 7) patients who did not undergo neuromuscular reversal
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Young Ju |
| Middle name | |
| Last name | Won |
Organization
Korea University Guro Hospital
Division name
Seoul
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul
TEL
82-2-2626-1437
moma2@naver.com
Public contact
Name of contact person
| 1st name | Seok Kyeong |
| Middle name | |
| Last name | Oh |
Organization
Korea University Guro Hospital
Division name
Seoul
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul
TEL
82-2-2626-1437
Homepage URL
nanprayboy@korea.ac.kr
Sponsor or person
Institute
Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Korea University Guro Hospital
Address
148, Gurodong-ro, Guro-gu, Seoul 08308, Korea
Tel
+82 2 2626 1635
ssessong@korea.ac.kr
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 | 09 | Month | 23 | 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
236
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study using datasets collected from medical records and clinical database.
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047799
