UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of EEG-based desflurane anesthesia and postoperative delirium
Acronym	A prospective study of EEG-based desflurane anesthesia and postoperative delirium
Scientific Title	A prospective study of EEG-based desflurane anesthesia and postoperative delirium
Scientific Title:Acronym	A prospective study of EEG-based desflurane anesthesia and postoperative delirium
Region	Japan

Condition
Condition	Not specified
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify that the incidence of delirium after desflurane anesthesia is lower in elderly patients who are managed at an appropriate depth of anesthesia based on anesthesia EEG. In this study, we will (1) record and analyze EEG during desflurane anesthesia using a general-purpose anesthesia depth monitor and a digital EEG monitor, and (2) examine the optimal desflurane concentration according to age based on the anesthesia EEG. The achievement of optimal-anesthesia depth control based on EEG analysis will improve the neurological prognosis of elderly patients and contribute to the prevention of postoperative delirium.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation with desflurane concentration, depth of anesthesia, and age
Key secondary outcomes	Calculation of optimal desflurane concentration for each age group

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 are patients who meet the following conditions. (1) Patients scheduled for abdominal surgery of 120 minutes or more at Tohoku University Hospital (2) Patients who require general anesthesia or general anesthesia with epidural anesthesia (3) Adult patients aged 20 years or older (4) Gender is not required.
Key exclusion criteria	(1) Patients with central nervous system disorders and psychiatric disorders (2) Patients who regularly use CNS-acting drugs (3) Patients who drink a lot of alcohol or use illegal drugs (4) Patients with a history or family history of malignant hyperthermia (5) Patients who cannot communicate in Japanese (6) Patients who had an adverse reaction to desflurane and required a change in anesthetic (7) Patients who could not be awakened and extubated in the operating room immediately after the completion of surgery
Target sample size	50

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	Tohoku University Center for Gender Equality Promotion
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
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	Preinitiation
Date of protocol fixation	2021 Year 04 Month 08 Day
Date of IRB	2021 Year 04 Month 15 Day
Anticipated trial start date	2021 Year 07 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

Registration in the UMIN clinical trial registration system Recruitment of adult patients scheduled for abdominal surgery of 120 minutes or longer at Tohoku University Hospital who require general anesthesia or general anesthesia with epidural anesthesia (50 patients in total) A. What to do in the clinic Before induction of general anesthesia, a general-purpose depth-of-anesthesia monitor (BIS) is applied, and EEG recording and depth-of-anesthesia monitoring are started. After securing the airway, start general anesthesia with desflurane and remifentanil. The concentration of desflurane is gradually increased until a group suppression wave (EEG indicating deep anesthesia) is observed. The biometric monitor and EEG data are automatically transferred and stored on the server in the operating room. B. What will be done in the study (additions to medical practice) Before induction of general anesthesia, install an additional digital EEG monitor and start recording. Titration of desflurane concentration should not be rapid, but 1% every 10 minutes. The biometric monitor and EEG data obtained during general anesthesia should be stored on a personal computer. C. Analysis of EEG data (for research purposes)

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=R000050742