UMIN-CTR Clinical Trial

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
Email	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
Email	nanprayboy@korea.ac.kr

Sponsor
Institute	Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047799