UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of the optimal depth of anesthesia for remimazolam anesthesia
Acronym	A prospective study on the depth of anesthesia for remimazolam anesthesia
Scientific Title	A prospective study of the optimal depth of anesthesia for remimazolam anesthesia
Scientific Title:Acronym	A prospective study on the depth of anesthesia for remimazolam anesthesia
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 was to analyze the EEG changes induced by the general anesthetic remimazolam and to verify whether a general-purpose anesthesia depth monitor based on EEG changes can be used appropriately.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG changes during remimazolam anesthesia
Key secondary outcomes	The validity of a commercially available depth of anesthesia monitor

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	Eligibility criteria are patients who meet the following conditions. (1) Patients scheduled for general anesthesia surgery with spinal subarachnoid anesthesia at Tohoku University Hospital (2) Adult patients aged 20 years or older (3) Gender is not required.
Key exclusion criteria	(1) Pregnant and lactating women (2) Patients with Child-Pugh classification C or higher (3) Patients with central nervous system diseases and psychiatric diseases (4) Patients who regularly use CNS-acting drugs (5) Heavy drinkers of alcohol and illegal drugs (6) Patients who cannot communicate in Japanese (7) Patients who had an adverse reaction to remimazolam and required a change in anesthetic (8) Patients who could not be awakened from anesthesia 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 general anesthesia surgery with spinal subarachnoid anesthesia at Tohoku University Hospital (50 patients in total) 1) What we will do in the clinic Perform spinal subarachnoid anesthesia and confirm that the anesthesia level necessary for surgery is obtained. 2) Perform general anesthesia before induction of general anesthesia. Before induction of general anesthesia, install a general-purpose depth-of-anesthesia monitor and begin EEG recording and depth-of-anesthesia monitoring. Induce general anesthesia with remimazolam and secure the airway. The biometric monitor and EEG data will be automatically transferred to the server in the operating room and stored. Remimazolam administration is discontinued at the end of surgery, and the patient is awakened. If the patient is not awake within 15 minutes after the administration of remimazolam, flumazenil will be administered. (2) What will be done in this study (additional items to medical practice) Before induction of general anesthesia, a digital EEG monitor will be additionally installed and recording will begin. The biometric monitor and EEG data obtained during general anesthesia will be stored on a personal computer. Analyze the EEG data (for research purposes). The EEG data recorded by the general anesthesia depth monitor and stored on the personal computer will be analyzed offline (frequency analysis will be performed by Bispectral Analyzer for BIS). Validation of the general anesthesia depth monitor (for research purposes). Calculate the value of the general anesthesia depth monitor when the power of alpha and beta waves is maximum for each patient.

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=R000050740