UMIN-CTR Clinical Trial

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
Email	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
Email	kotoe.kamata.c3@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050736