UMIN-CTR Clinical Trial

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
Institute	Sapporo Medical University School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049614