UMIN-CTR Clinical Trial

Basic information
Public title	Remimazolam during induction of anesthesia in patients with severe aortic stenosis
Acronym	Remimazolam during induction of anesthesia in patients with severe aortic stenosis
Scientific Title	Remimazolam during induction of anesthesia in patients with severe aortic stenosis
Scientific Title:Acronym	Remimazolam during induction of anesthesia in patients with severe aortic stenosis
Region	Japan

Condition
Condition	Severe aortic stenosis
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the hemodynamic changes and time to loss of consciousness following the induction of general anesthesia with remimazolam in patients with severe aortic stenosis. We will also collect data from patients who were used midazolam for induction of anesthesia retrospectively and compare them to remimazolam for hemodynamic and other changes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dosage of vasoconstrictor and inotropic agents during induction of anesthesia.
Key secondary outcomes	Hemodynamic change (blood pressure and heart rate). Time to loss of consciousness, time from the start of anesthesia induction to the end of tracheal intubation, total remimazolam dose, change in BIS (bispectral index) level, change in TOI (tissue oxygenation index), postoperative nausea and vomiting, incidence of postoperative delirium, presence or absence of awareness at the time of induction of anesthesia, and postoperative flumazenil use and dose.

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	Patients with a diagnosis of severe aortic stenosis on a preoperative transthoracic echocardiogram.
Key exclusion criteria	(1) Patients undergoing emergency surgery (2) Patients who are allergic to the study drugs (fentanyl, remifentanil, rocuronium, sugammadex, benzodiazepines, sevoflurane, desflurane) (3) Patients for whom the use of remimazolam is contraindicated (patients with acute angle-closure glaucoma, myasthenia gravis, shock, coma, and acute alcoholism with suppressed vital signs) (4) Patients with preoperative disturbance of consciousness (5) Patients who have been sedated preoperatively (6) Patients deemed inappropriate by the principal investigator/associators (excluded with reasons for exclusion)
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Nakanishi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	467-8601
Address	Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-851-5511
Email	nakanishi.anest@gmail.com

Public contact
Name of contact person	1st name Toshiyuki Middle name Last name Nakanishi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	467-8601
Address	Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-851-5511
Homepage URL
Email	nakanishi.anest@gmail.com

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences, Department of Anesthesiology and Intensive Care Medicine
Institute
Department

Funding Source
Organization	None.
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	Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address	Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	052-851-5511
Email	clinical_research@med.nagoya-cu.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	2020 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01530-3
Number of participants that the trial has enrolled	20
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	Completed
Date of protocol fixation	2020 Year 10 Month 07 Day
Date of IRB	2020 Year 10 Month 14 Day
Anticipated trial start date	2020 Year 11 Month 05 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

In this study, we will use remimazolam for induction of general anesthesia in patients with severe aortic stenosis and observe hemodynamic changes, time to loss of consciousness, and so on. The other observations of the study were as follows. Age, gender, height, weight, ASA PS, comorbidities, NYHA classification, and Hugh-Jones classification. Transthoracic echocardiographic measurements (LVDd/Ds, LVEF, E/A/DcT, E/e', maximal flow velocity through the aortic valve, maximal pressure gradient, mean pressure gradient, aortic valve area, left ventricular outflow tract blood flow velocity/aortic valve blood flow velocity, other degrees of valvular disease, tricuspid valve regurgitation pressure gradient, etc.) Twelve-lead ECG readings: heart rate, presence of arrhythmia, etc. Chest x-ray: cardiothoracic ratio, presence of pleural effusion Blood test: Hemoglobin, BUN, creatinine, NT-proBNP, HbA1c Time from the start of anesthesia induction to the end of tracheal intubation, blood pressure (systolic, diastolic, mean blood pressure) according to arterial pressure waveforms, heart rate, BIS level, cerebral tissue oxygenation. The amount of remimazolam used, the type and amount of circulating agonists used (e.g. ephedrine, phenylephrine, atropin, noradrenaline, adrenaline, dobutamine, dopamine, and nicardipine) Flumazenil use and dosage, operative time, postoperative ventilatory time, CAM-ICU (Confusion assessment method for the ICU) assessment of delirium, awareness at the time of intubation, nausea and vomiting up to the second postoperative day, and number of days in the ICU. We will collect 40 background-matched patients' data with severe aortic stenosis who were previously induced with midazolam retrospectively (1:2 matching) and compare the dosage of vasoconstrictor and inotropic drugs, hemodynamic changes, incidence of postoperative delirium, and so on.

Management information
Registered date	2020 Year 11 Month 02 Day
Last modified on	2021 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048304