UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050016 |
|---|---|
| Receipt number | R000056978 |
| Scientific Title | The effects of anesthetics on intracranial pressure: Additional analysis |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2024/01/13 13:25:40 |
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Basic information
Public title
The effects of anesthetics on intracranial pressure: Additional analysis
Acronym
Anesthetics & intracranial pressure
Scientific Title
The effects of anesthetics on intracranial pressure: Additional analysis
Scientific Title:Acronym
Anesthetics & intracranial pressure
Region
| Japan |
Condition
Condition
Healthy adult volunteers (opt-out)
Target population; Patients undergoing sedation or general anesthesia
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of present study is to investigate effects of anesthetics on intracranial pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of Noninvasive ICP (nICP) during sedation or anesthesia
Key secondary outcomes
Cerebral blood flow (CBF), arterial blood pressure, cerebrovascular resistance, CBF pulsatility index (PI), etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male
Key inclusion criteria
The participants who were taken part in the original study performed by Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine in 2004, 2006, and 2007. The written informed consent was obtained in the original study to investigate the effects of anesthetics on cerebral circulation.
Key exclusion criteria
Participants who desire withdraw from the present study via opt-out.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Yojiro |
| Middle name | |
| Last name | Ogawa |
Organization
Nihon University School of Medicine
Division name
Department of Social Medicine, Division of Hygiene
Zip code
173-8610
Address
30-1, Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
ogawa.yojiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yojiro |
| Middle name | |
| Last name | Ogawa |
Organization
Nihon University School of Medicine
Division name
Department of Social Medicine, Division of Hygiene
Zip code
173-8610
Address
30-1, Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
ogawa.yojiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
A laboratory foundation of Nihon University School of Medicine
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
Nihon University School of Medicine
Address
30-1, Oyaguchi-kamicho, Iabashi-ku, Tokyo
Tel
03-3972-8111
med.kenjim@nihon-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
| 2023 | Year | 01 | 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
42
Results
The present study is a follow-up on our earlier research series, and is based on reanalysis of the data obtained from the previous research series.
Participants were given the opportunity to decline consent using an opt-out method; none of the participants requested withdrawal from the study.
To estimate ICP during sedation, we analyzed the data from 42 healthy male volunteers whose waveforms were available for calculation of nICP in the previous research series.
Results date posted
| 2023 | Year | 07 | Month | 15 | Day |
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study is an additional analysis of the previous data. The previous data are obtained from an intervention experiment in which healthy adult volunteers were administered various sedative and anesthetic drugs, such as nitrous oxide (n=7), sevoflurane (n=11), dexmedetomidine (n=14), propofol (n=15), and midazolam (n=16). The written informed consent was obtained in the original study approved by the IRB.
Management information
Registered date
| 2023 | Year | 01 | 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/icdr_e/ctr_view.cgi?recptno=R000056978
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| Registered date | File name |
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