Cesarean SectionNCT06327165
Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension
An observational study of Cesarean Section and Spinal Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Spinal Anesthesia
- What is being tested?
- observation
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2024to 31 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: ANI monitor will be applied to all patients, but will be covered with black papar so that it could not be observed during anesthesia. ANI data recorded at 1 second intervals will be downloaded at the end of anesthesia.
Who may be able to join
- full-term parturients undergoing cesarean delivery
Who cannot join
- emergent surgery, placenta previa, Morbid obesity with a BMI ≥ 40 kg/m2, Gestational age < 36 or ≥ 41 weeks, Contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ANI monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health system, Severance Hospital
Seoul
Seung Hyun Kim, Associate Professor, 82-2-2224-1055, anesshkim@yuhs.ac
About this study
Official title: Predictability of ANI (Analgesia Nociception Index) for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol.
- Conditions
- Cesarean Section, Spinal Anesthesia
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Women undergoing cesarean section under spinal anesthesia with ANI monitor applied Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of ANI monitor for spinal hypotension during cesarean delivery
Investigators will determine the predictive power of the ANI score change for the occurrence of hypotension after spinal anesthesia by drawing a receiver operating characteristic (ROC) curve of the change in ANI score (baseline value - minimum value) and calculating the area under the ROC curve.
Measured: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Secondary outcomes (1)
Optimal cutoff value of ANI level for predicting occurrence of hypotension
Investigators will determine the optimal cutoff value of ANI level for predicting hypotension after spinal anesthesia.
Measured: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start18 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Yonsei UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327165
- Sponsor's protocol ID
- 1-2023-0072
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of ANI (Analgesia Nociception Index) for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT06327165
- Acronym / sponsor ID
- 1-2023-0072
- Conditions
- Cesarean Section, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Mar 2024 (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.
Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | Other: observationWomen undergoing cesarean section under spinal anesthesia with ANI monitor applied |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ANI monitor will be applied to all patients, but will be covered with black papar so that it could not be observed during anesthesia. ANI data recorded at 1 second intervals will be downloaded at the end of anesthesia.
Key inclusion criteria (1 listed)
- full-term parturients undergoing cesarean delivery
Key exclusion criteria (1 listed)
- emergent surgery, placenta previa, Morbid obesity with a BMI ≥ 40 kg/m2, Gestational age < 36 or ≥ 41 weeks, Contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ANI monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners
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 |
|---|---|---|
| observationThe ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. | Other | pregnant women |
Primary outcome
predictive value of ANI monitor for spinal hypotension during cesarean delivery
Time frame: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Investigators will determine the predictive power of the ANI score change for the occurrence of hypotension after spinal anesthesia by drawing a receiver operating characteristic (ROC) curve of the change in ANI score (baseline value - minimum value) and calculating the area under the ROC curve.
1 secondary outcome
Optimal cutoff value of ANI level for predicting occurrence of hypotension
Time frame: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 and Spinal Anesthesia, run by Yonsei University 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 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Hyun Kim, Associate Professor (82-2-2224-1055, anesshkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive value of ANI monitor for spinal hypotension during cesarean delivery (time frame: the occurence of hypotension at (within) 1 hour after spinal anesthesia). 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 Mar 2024.