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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042587
Receipt No. R000048218
Scientific Title A comparative study of remimazolam and propofol in the incidence of hypotension during induction of general anesthesia for the elderly: a randomized controlled trial
Date of disclosure of the study information 2021/06/30
Last modified on 2021/08/04

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Basic information
Public title Frequency of hypotension during induction of general anesthesia with remimazolam in the elderly
Acronym Frequency of hypotension during induction of general anesthesia with remimazolam
Scientific Title A comparative study of remimazolam and propofol in the incidence of hypotension during induction of general anesthesia for the elderly: a randomized controlled trial
Scientific Title:Acronym A comparative study of remimazolam and propofol in the incidence of hypotension during induction of general anesthesia: a randomized controlled trial
Region
Japan

Condition
Condition Elective surgery by general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing the incidence of hypotension after induction of general anesthesia between remimazolam and propofol
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Incidence of hypotension between induction and 3 minutes after intubation
Hypotension was defined as mean arterial pressure bellow 65mmHg.
Key secondary outcomes Maximum arterial pressure after intubation
Lowest heart rate
Number of using vasopressor
Time between induction and loss of consciousness
Dose of sedative drug for anesthesia induction
Incidence of injection pain
Characteristics



Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction of general anesthesia with remimazolam (12mg/kg/hr)
Interventions/Control_2 Induction of general anesthesia with propofol (0.25mg/kg/10sec)
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients underwent an elective operation performed by general anesthesia with rapid induction using oral intubation with single lumen tube
Non-cardiovascular surgery
ASA-PS 1 to 3
Patients who are able to communicate and obtain consent from themselves
Key exclusion criteria Patients with:
Aortic aneurysms
Cerebral aneurysms
Difficulty of mask ventilation or intubation
Drug allergy of propofol or benzodiazepines
Hemodialysis
Severe liver failure (i.e. Child-Pugh C)
Unstable or untreated ischemic heart disease
Severe arterial or mitral valve regurgitation or stenosis
Arterial fibrillation
Supra ventricular or ventricular premature contraction
Congestive heart failure (NYHA3 or 4)
Body mass index >= 30
Using antipsychotic drugs
Mean blood pressure less than 70 mmHg immediately before the start of anesthesia
Cases in which multiple tracheal intubations were required
Cases the physician was considered inappropriate
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Yokose
Organization Yokohama City University Hospital
Division name Department of anesthesiology and Critical Care Medicine
Zip code 2360004
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL +81457872800
Email yokose_p12@yahoo.co.jp

Public contact
Name of contact person
1st name Ryuki
Middle name
Last name Takaki
Organization Yokohama City University Hospital
Division name Department of anesthesiology and Critical Care Medicine
Zip code 2360004
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL +81457872800
Homepage URL
Email ryuki.takaki218@gmail.com

Sponsor
Institute Yokohama City University
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 The institutional ethics committee of Yokohama city university hospital
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel +81457872800
Email rinri@yokohama-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
2021 Year 06 Month 30 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 Enrolling by invitation
Date of protocol fixation
2021 Year 04 Month 30 Day
Date of IRB
2021 Year 02 Month 15 Day
Anticipated trial start date
2021 Year 06 Month 30 Day
Last follow-up date
2023 Year 05 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
2020 Year 11 Month 28 Day
Last modified on
2021 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048218

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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