Cesarean SectionNCT04979039
Heart Rate Variability to Predict Hypotension Following Spinal Anesthesia in Cesarean Delivery
An observational study of Cesarean Section, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Based on the patient's heart rate variability, the analgesia nociception index (ANI) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- analgesia nociception index (ANI) monitoring
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 28 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult pregnant women scheduled for cesarean section under spinal anesthesia
Who may be able to join
- Adult pregnant women scheduled for cesarean section under spinal anesthesia
Who cannot join
- Emergency cesarean section
- When performing general anesthesia or epidural anesthesia
- Multiple pregnancies
- Surgery in which massive hemorrhage and massive blood transfusion are expected due to placenta previa
- Cardiac arrhythmias, congestive heart failure, ischemic heart disease, congenital heart anomalies
- Cranial nervous system disease
Show all 9Show fewer
- Autonomic nervous system-related underlying diseases not related to pregnancy
- Fetal malformations
- Those who have an allergic skin reaction to adhesive substances such as bandages
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Heart Rate Variability Monitoring to Predict Hypotension Following Spinal Anesthesia for Cesarean Delivery: Prospective Observational Study
Based on the patient's heart rate variability, the analgesia nociception index (ANI) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. The investigators will analyze it and see if it has the ability to predict severe hypotension following spinal anesthesia.
- Conditions
- Cesarean Section
- Being tested
- analgesia nociception index (ANI) monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesia nociception index (ANI) monitoringOther
The ANI monitor starts lying on the bed in the waiting area before entering the operating room, and the monitoring period should be at least 15 minutes. After entering the operating room, monitoring begins again and is maintained during the operation.
| Study group | Role | What they receive |
|---|---|---|
| normal pregnancy | Adult pregnant women scheduled for cesarean section under spinal anesthesia Receives: Other: analgesia nociception index (ANI) monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of averaged value
The change of averaged value presented in ANI monitor
Measured: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room
The change of instantaneous value
The change of instantaneous value presented in ANI monitor
Measured: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room
Total dose of injected phenylephrine
Measured: During the anesthesia (from initiation of anesthesia until the end of anesthesia)
Total dose of injected glycopyrrolate
Measured: During the anesthesia (from initiation of anesthesia until the end of anesthesia)
The change of systolic blood pressure
Measured: Every 1 min after entering the operating room until finishing the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Jun 2023
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979039
- Sponsor's protocol ID
- HRV Csec Spinal HypoT
- Status last verified
- Jan 2025
- First submitted
- 30 Jun 2021
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability Monitoring to Predict Hypotension Following Spinal Anesthesia for Cesarean Delivery: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04979039
- Acronym / sponsor ID
- HRV Csec Spinal HypoT
- Conditions
- Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on the patient's heart rate variability, the analgesia nociception index (ANI) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. The investigators will analyze it and see if it has the ability to predict severe hypotension following spinal anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal pregnancy | – | Other: analgesia nociception index (ANI) monitoringAdult pregnant women scheduled for cesarean section under spinal anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult pregnant women scheduled for cesarean section under spinal anesthesia
Key inclusion criteria (1 listed)
- Adult pregnant women scheduled for cesarean section under spinal anesthesia
Key exclusion criteria (9 listed)
- Emergency cesarean section
- When performing general anesthesia or epidural anesthesia
- Multiple pregnancies
- Surgery in which massive hemorrhage and massive blood transfusion are expected due to placenta previa
- Cardiac arrhythmias, congestive heart failure, ischemic heart disease, congenital heart anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analgesia nociception index (ANI) monitoringThe ANI monitor starts lying on the bed in the waiting area before entering the operating room, and the monitoring period should be at least 15 minutes. After entering the operating room, monitoring begins again and is maintained during the operation. | Other | normal pregnancy |
Primary outcome
The change of averaged value
Time frame: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room
The change of averaged value presented in ANI monitor
The change of instantaneous value
Time frame: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room
The change of instantaneous value presented in ANI monitor
Total dose of injected phenylephrine
Time frame: During the anesthesia (from initiation of anesthesia until the end of anesthesia)
Total dose of injected glycopyrrolate
Time frame: During the anesthesia (from initiation of anesthesia until the end of anesthesia)
The change of systolic blood pressure
Time frame: Every 1 min after entering the operating room until finishing the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of averaged value (time frame: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.