UMIN-CTR Clinical Trial

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
Email	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
Email	suehirokoichi@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050510