UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047469 |
|---|---|
| Receipt number | R000052974 |
| Scientific Title | Relationships between patient's physiological variables and drugs in the perioperative period |
| Date of disclosure of the study information | 2022/04/15 |
| Last modified on | 2022/05/16 13:21:06 |
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Basic information
Public title
Relationships between patient's physiological variables and drugs in the perioperative period
Acronym
Relationships between patient's physiological variables and drugs in the perioperative period
Scientific Title
Relationships between patient's physiological variables and drugs in the perioperative period
Scientific Title:Acronym
Relationships between patient's physiological variables and drugs in the perioperative period
Region
| Japan |
Condition
Condition
Neurosurgery patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of differences in physiological parameters between propofol and remimazolam anesthesia (non-inferiority)
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitudes in operative SEP
Non-inferiority margin in amplitude set based on values of 50% reduction of the control drug.
Key secondary outcomes
Comparison and assessment of bioequivalence in perioperative clinical data (hemodynamics, electrophysiological intraoperative monitoring, clinical information, and so on)
Assessments of non-inferiority
Amplitudes and latencies in evoked potentials.
Estimation with confidence intervals
Non-inferiority margin in amplitude and latency set based on values of 50% reduction and 10% delay of the control drug.
Detailed analysis for hemodynamic variables
Factorial analysis for interactions of hemodynamics
Analysis for electrophysiological intraoperative monitoring
BP, HR, SEP, MEP, ABR, VEP, BIS, and so on.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
Induction and maintenance of anesthesia are performed using propofol.
Interventions/Control_2
Induction and maintenance of anesthesia are performed using remimazolam.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who are scheduled to undergo neurosurgery at Ina Central Hospital.
Key exclusion criteria
Cases in which consent was not obtained
Severe cardiac disease
Severe lung disease
Severe liver dysfunction
Severe renal dysfunction
Severe metabolism disorders
Obese cases with a BMI of 30 or higher
Cases in which securing the airway is difficult
Others that the investigators consider to be inappropriate for a participant of the study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Shiratori |
Organization
Ina Central Hospital
Division name
Medical department
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano, Japan
TEL
0265-72-3121
tohru_shiratori@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Shiratori |
Organization
Ina Central Hospital
Division name
Medical department
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina, Nagano, Japan
TEL
0265-72-3121
Homepage URL
tohru_shiratori@yahoo.co.jp
Sponsor or person
Institute
Ina Central Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Ethical committee of Ina Central Hospital
Address
1313-1 koshiroukubo, Ina, Nagano, Japan
Tel
0265-72-3121
admin@inahp.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
| 2022 | Year | 04 | Month | 15 | 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
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 04 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052974
| 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 |
