UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042587 |
|---|---|
| Receipt number | 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 | 2024/06/01 23:12:13 |
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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
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
ryuki.takaki218@gmail.com
Sponsor or person
Institute
Yokohama City University
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
The institutional ethics committee of Yokohama city university hospital
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
+81457872800
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
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0275451
Publication of results
Published
Result
URL related to results and publications
https://www.bjanaesthesia.org/article/S0007-0912(24)00212-5/abstract
Number of participants that the trial has enrolled
90
Results
The incidence of hypotension during anesthesia induction was 72.1% (31 patients) in the remimazolam group (43 patients) and 72.7% (32 patients) in the propofol group (44 patients), with no statistically significant difference (odds ratio, 0.96 [95% confidence interval, 0.37-2.46], p = 0.93). None of the subgroup analyses showed statistically significant differences. The number of times patients used vasopressors was not statistically significant (p=0.31).
Results date posted
| 2024 | Year | 06 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age, remi 82 [81-84] prop 82 [81-86]
Sex, female remi 19 (44.2) prop 24 (54.5)
Height, cm remi 156.7 (7.4) prop 155.3 (10.3)
Weight, kg remi 57.6 (8.3) prop 55.5 (9.0)
Charlson Comorbidity Index score remi 2 [1-2] prop 2 [0-2]
Clinical frailty scale remi 3 [3-3] prop 3 [3-4]
ASA physical status 1-2/3 remi 41/2 prop 42/2
Participant flow
Assessed for eligibility, n=453 Eligible to participate, n=90 Randomized (n=89) Allocated to remimazolam group (n=44) Allocated to propofol group (n=45)
Analyzed Remimazolam group (n=43) Propofol group (n=44)
Adverse events
No serious adverse events
Outcome measures
The incidence of hypotension during anesthesia induction was 72.1% (31 patients) in the remimazolam group (43 patients) and 72.7% (32 patients) in the propofol group (44 patients), with no statistically significant difference (odds ratio, 0.96 [95% confidence interval, 0.37-2.46], p=0.93).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 06 | Month | 10 | 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
| 2024 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048218
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| Registered date | File name |
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