UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042318 |
|---|---|
| Receipt number | R000048304 |
| Scientific Title | Remimazolam during induction of anesthesia in patients with severe aortic stenosis |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2021/12/08 08:19:24 |
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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
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
nakanishi.anest@gmail.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences, Department of Anesthesiology and Intensive Care Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048304
