UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044229 |
|---|---|
| Receipt number | R000050510 |
| Scientific Title | The ability of changes in carotid corrected flow time to predict spinal anesthesia-induced hypotension in cesarean delivery |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2021/05/17 11:31:08 |
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Basic information
Public title
The ability of changes in carotid corrected flow time to predict spinal anesthesia-induced hypotension in cesarean delivery
Acronym
The ability of changes in carotid corrected flow time to predict spinal anesthesia-induced hypotension in cesarean delivery
Scientific Title
The ability of changes in carotid corrected flow time to predict spinal anesthesia-induced hypotension in cesarean delivery
Scientific Title:Acronym
The ability of changes in carotid corrected flow time to predict spinal anesthesia-induced hypotension in cesarean delivery
Region
| Japan |
Condition
Condition
Patients undergoing cesarean delivery under spinal anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictability of changes in carotid corrected flow time for the incidence of hypotension induced by spinal anesthesia in cesarean delivery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of hypotension after spinal anesthesia
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing cesarean delivery under spinal anesthesia
Key exclusion criteria
1) Emergency cases
2) Patients with atrial fibrillation
3) Patients who cannot tolerate the head-down position
4) Non-reassuring fetal status
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
suehirokoichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka City University Graduate School of Medicine
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
Ethics Committee of Osaka City University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
81-6-6646-6125
ethics@med.osaka-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 | 05 | Month | 17 | 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
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before the induction of spinal anesthesia, carotid corrected flow time (FTc) is measured in supine and head-down (15 degree) position. Spinal anesthesia is performed using hyperbaric bupivacaine and fentanyl. Hemodynamic variables including blood pressure, stroke volume and stroke volume variation are measured using the ClearSight system throughout the study. Hypotension is defined as the followings: systolic blood pressure < 90mmHg or more than 20% decrease in systolic blood pressure from the baseline values. When hypotension occurs, vasoactive agents including ephedrine or phenylephrine are administered.
All subjects are divided into "Hypotension group" or "Non-hypotension group" according to the blood pressure values after spinal anesthesia. Receiver operating characteristic curve of changes in FTc (induced by preoperative position change) is constructed to investigate the predictability for the incidence of hypotension after spinal anesthesia.
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050510
