UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043447
Receipt number R000049614
Scientific Title Differential effects of propofol and remimazolam on heart rate variability during anesthetic induction
Date of disclosure of the study information 2021/03/01
Last modified on 2022/02/27 09:40:04

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Basic information

Public title

Effects of remimazolam on heart rate variability

Acronym

Effects of remimazolam on heart rate variability

Scientific Title

Differential effects of propofol and remimazolam on heart rate variability during anesthetic induction

Scientific Title:Acronym

Differential effects of propofol and remimazolam on heart rate variability during anesthetic induction

Region

Japan


Condition

Condition

The patients who receive general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the effects of remimazolam on autonomic nerve activity using a heart rate variability analysis.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in heart rate variability before and after anesthetic induction with propofol or remimazolam

Key secondary outcomes

Changes in blood pressure and heart rate before and after anesthetic induction with propofol for remimazolam


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Surgical patients were randomized to remimazolam started at 12 mg/kg/h by continuous intravenous (IV) infusion until the loss of consciousness (LoC), followed by 1 mg/kg/h to be adjusted as appropriate until the end of surgery

Interventions/Control_2

Surgical patients were randomized to propofol started at 0.05mL/kg/10s by continuous intravenous (IV) infusion until the loss of consciousness (LoC), followed by 1.0 mL/kg/h to be adjusted as appropriate until the end of surgery.

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

18 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

Relevant inclusion criteria included over 18 years old, a bodyweight of 100 kg or less, scheduled for elective surgery requiring tracheal intubation and an American Society
of Anesthesiologists physical status of 1 or 2

Key exclusion criteria

Key exclusion criteria included emergency surgeries or
patients with consciousness disturbance, drug dependence, alcohol dependence, uncontrolled hypertension, acute angle-closure glaucoma, myasthenia gravis, renal failure, massive hemorrhage, shock and pregnant and nursing women.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Naoyuki
Middle name
Last name Hirata

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code

060-8543

Address

S1, W16, Chuo-ku, Sapporo

TEL

011-611-2111

Email

naohirata@mac.com


Public contact

Name of contact person

1st name Naoyuki
Middle name
Last name Hirata

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code

060-8543

Address

S1, W16, Chuo-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

naohirata@mac.com


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Sapporo Medical University School of Medicne

Address

S1, W16, Chuo-ku, Sapporo

Tel

011-611-2111

Email

ji-rskk@sapmed.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 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00540-022-03037-8

Number of participants that the trial has enrolled

30

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 01 Month 13 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 02 Month 12 Day

Date of IRB

2021 Year 02 Month 12 Day

Anticipated trial start date

2021 Year 03 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 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 02 Month 26 Day

Last modified on

2022 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049614


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name