UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044311
Receipt number R000050613
Scientific Title Effects on the cardiac conduction system revealed by analysis of heart rate variability in the use of Remimazolam (Single-blind, a prospective test)
Date of disclosure of the study information 2021/06/01
Last modified on 2023/01/24 07:01:18

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Basic information

Public title

The study of the effects of general anesthesia using Remimazolam on vital signs such as cardiovascular and blood pressure in surgical patients

Acronym

Effects of Remimazolam on Vital Signs in General Anesthetized Patients

Scientific Title

Effects on the cardiac conduction system revealed by analysis of heart rate variability in the use of Remimazolam (Single-blind, a prospective test)

Scientific Title:Acronym

Effects of Remimazolam on the cardiac conduction system (Single-blind, prospective study)

Region

Japan


Condition

Condition

All diseases that require surgery under general anesthesia

Classification by specialty

Surgery in general Obstetrics and Gynecology Ophthalmology
Dermatology Oto-rhino-laryngology Orthopedics
Urology Anesthesiology Neurosurgery
Cardiovascular surgery Plastic surgery Operative medicine
Emergency medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

By comparing with the anesthetics used so far, it is shown that it is not inferior to the anesthetics used so far ,and in order to prove by heart rate variability analysis that the effect on hemodynamics, which is the merit and advantage of Remimazolam, is small.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1, ECG (RR interval, Tp-e, QTc time)
2, Blood pressure
3, Heart rate, pulse rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Induce anesthesia using Remimazolam.

Interventions/Control_2

Induce anesthesia using Propofol.

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

1) Patients undergoing general anesthesia, regardless of gender.
2) Patients scheduled to undergo mechanical ventilation management by tracheal intubation
3) Patients with ASA classification I or II
4) Patients who can fully explain the complications, indications, and disadvantages associated with inferior alveolar nerve conduction anesthesia using detailed explanatory documents, and obtain written consent (informed consent) at their own will.

Key exclusion criteria

1) Patients under the age of 20 at the time of obtaining the consent form
2) Patients with allergies, hypersensitivity or tolerance to the drugs used
3) Patients who meet the contraindications listed in the package insert of the drug to be used
4) Patients with AST (GOT) or ALT (GPT) of 100 IU / L or more in preoperative general clinical examination
5) Patients with Child-Pugh classification B or C
6) Patients with serum creatinine of 2.0 mg / dL or higher in general preoperative laboratory tests
7) Patients who have been using benzodiazepines for a long time
8) Patients with organic abnormalities in the brain who may not be able to properly measure EEG and BIS values
9) Patients scheduled to undergo epidural anesthesia / spinal anesthesia
10) Patients with cardiac pacemakers and ICDs
11) Lactating patients (except with the positive consent of the patient)
12) Other patients judged to be inappropriate by the principal investigator

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Shota
Middle name
Last name Tsukimoto

Organization

Kindai University Faculty of Medicine

Division name

Dapartment of Anesthesiology

Zip code

589-8511

Address

377-2, onohigashi, osaka-sayama, Osaka, Japan

TEL

072-366-0221

Email

s-tsukimoto@med.kindai.ac.jp


Public contact

Name of contact person

1st name Shota
Middle name
Last name Tsukimoto

Organization

Kindai University Faculty of Medicine

Division name

Dapartment of Anesthesiology

Zip code

589-8511

Address

377-2, onohigashi, osaka-sayama, Osaka, Japan

TEL

072-366-0221

Homepage URL


Email

s-tsukimoto@med.kindai.ac.jp


Sponsor or person

Institute

Kindai University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

no funding source

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

Kindai University Faculty of Medicine Ethics Committee

Address

377-2, onohigashi, osaka-sayama, Osaka, Japan

Tel

072-366-0221

Email

zizen@med.kindai.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 01 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

Terminated

Date of protocol fixation

2021 Year 06 Month 01 Day

Date of IRB

2021 Year 06 Month 01 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 25 Day

Last modified on

2023 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050613


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name