UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044837 |
|---|---|
| Receipt number | R000051111 |
| Scientific Title | Rapid sequence induction in patients with esophageal achalasia: remimazolam vs propofol |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2024/01/13 09:37:48 |
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Basic information
Public title
Rapid sequence induction in patients with esophageal achalasia: remimazolam vs propofol
Acronym
Rapid sequence induction in patients with esophageal achalasia: remimazolam vs propofol
Scientific Title
Rapid sequence induction in patients with esophageal achalasia: remimazolam vs propofol
Scientific Title:Acronym
Rapid sequence induction in patients with esophageal achalasia: remimazolam vs propofol
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether remimazolam is equivalent or more useful for rapid sequence induction than propofol in patients with esophageal achalasia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from start of remimazolam or propofol administration to loss of consciousness
Key secondary outcomes
Time from start of remimazolam or propofol administration to respiratory arrest, dose of remimazolam or propofol for loss of consciousness, injection pain, time from start of remimazolam or propofol administration to completion of tracheal intubation,
hemodynamics during anesthesia induction, and electroencephalographic change during anesthesia induscion
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
anesthesia induction with remimazolam
Interventions/Control_2
anesthesia induction with 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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients undergoing elective surgery for esophageal achalasia in Showa University Koto Toyosu Hospital
2) 20 to 50 years old
3) patients who have given their written informed consent to participate in the research
Key exclusion criteria
1) allergy to benzodiazepine, propofol, inhalation anesthetics, or soybeans
2) history or family history of malignant hyperthermia
3) chronic intake of benzodiazepine
4) pregnancy
5) neurological disorders that may affect the electroencephalographic waveform
6) American Society of Anesthesiologist physical status 3 or above
7) patients who have been judged ineligible by the anesthesiologists in charge of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Nagane |
Organization
Showa University Koto Toyosu Hospital
Division name
Anesthesiology
Zip code
135-8577
Address
38-1-5 Toyosu Koto Tokyo Japan
TEL
0362046162
nagane@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Nagane |
Organization
Showa University Koto Toyosu Hospital
Division name
Anesthesiology
Zip code
135-8577
Address
38-1-5 Toyosu Koto Tokyo Japan
TEL
0362046162
Homepage URL
nagane@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Koto Toyosu Hospital
Address
38-1-5 Toyosu Koto Tokyo Japan
Tel
0362046162
nagane@med.showa-u.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 | 07 | Month | 12 | 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
Suspended
Date of protocol fixation
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051111
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
