UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053529 |
|---|---|
| Receipt number | R000061091 |
| Scientific Title | Nociceptive monitoring predicts hypotension during induction of general anesthesia: a single-center prospective observational study. |
| Date of disclosure of the study information | 2024/02/05 |
| Last modified on | 2024/02/03 17:20:45 |
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Basic information
Public title
Nociceptive monitoring predicts hypotension during induction of general anesthesia: a single-center prospective observational study.
Acronym
Nociceptive monitoring predicts hypotension during induction of general anesthesia: a single-center prospective observational study.
Scientific Title
Nociceptive monitoring predicts hypotension during induction of general anesthesia: a single-center prospective observational study.
Scientific Title:Acronym
Nociceptive monitoring predicts hypotension during induction of general anesthesia: a single-center prospective observational study.
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The value of the nociceptive monitor is to predict hypotension during induction of general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in HFVI/NOL between non-hypotensive and hypotensive groups
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia
Patients over 65 years of age (since the risk of hypotension is older and the balance of the autonomic nervous system differs between the elderly and the young, we will unify the patients in this study with the elderly)
Patients who have given consent for the study
Key exclusion criteria
Patients allergic to propofol
Patients taking drugs that affect the autonomic nervous system (beta blockers, drugs for psychiatric disorders)
Patients with ASA-PS (American Society of Anesthesiologists Physical Status) 3 or higher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | MASAHIRO |
| Middle name | |
| Last name | KUROKI |
Organization
Yamagata University Hospital
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata City, Yamagata, Japan
TEL
0236285400
m_kuroki@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | MASAHIRO |
| Middle name | |
| Last name | KUROKI |
Organization
Yamagata University Hospital
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata City, Yamagata, Japan
TEL
0236285400
Homepage URL
m_kuroki@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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 Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-nishi, Yamagata City, Yamagata, Japan
Tel
0236285400
m_kuroki@med.id.yamagata-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
| 2024 | Year | 02 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before general anesthesia, a nociceptive monitor is placed and HFVI and NOL values are obtained.
Induction of anesthesia is performed with remifentanil and propofol.
Measure blood pressure every minute for 5 minutes.
If the systolic arterial blood pressure falls below 80 mmHg at least once in 5 minutes, the patient is in the hypotensive group; if it does not fall below 80 mmHg, the patient is in the non-hypotensive group.
Management information
Registered date
| 2024 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061091
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
