Postspinal HypotensionNCT06847737
Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods
An observational study of Postspinal Hypotension, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postspinal Hypotension
- What is being tested?
- perfusion index
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Fifty pregnant women over the age of 18 who underwent elective cesarean section, were American Society of Anesthesia I and II, and agreed to participate in the study.
Who may be able to join
- Those who underwent elective cesarean section over the age of 18,
- American Society of Anesthesia I and II,
- Agree to participate in the study,
Who cannot join
- <18 or >45 years,
- preeclampsia,
- cardiovascular disorders,
- fetal abnormalities,
- not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
- not agreeing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods: Comparative Analysis of Perfusion Index, Pulse Variability Index, Tissue Oxygen Saturation and Tissue Hemoglobin Index
To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.
- Conditions
- Postspinal Hypotension
- Being tested
- perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion indexDiagnostic test
Also called pleth variability index, tissue hemoglobin index, tissue oxygen saturation
To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygen saturation
which indicates an increase in local tissue perfusion
Measured: 4 month
tissue hemoglobin index
indicating vasodilation
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postspinal HypotensionStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847737
- Sponsor's protocol ID
- haseki nırs masimo
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12.
PubMed 22798273Kuwata S, Suehiro K, Juri T, Tsujimoto S, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Pleth variability index can predict spinal anaesthesia-induced hypotension in patients undergoing caesarean delivery. Acta Anaesthesiol Scand. 2018 Jan;62(1):75-84. doi: 10.1111/aas.13012. Epub 2017 Oct 16.
PubMed 29034983Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.
PubMed 28890560
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods: Comparative Analysis of Perfusion Index, Pulse Variability Index, Tissue Oxygen Saturation and Tissue Hemoglobin Index
- ClinicalTrials.gov ID
- NCT06847737
- Acronym / sponsor ID
- haseki nırs masimo
- Conditions
- Postspinal Hypotension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 26 Feb 2025 (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.
To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fifty pregnant women over the age of 18 who underwent elective cesarean section, were American Society of Anesthesia I and II, and agreed to participate in the study.
Key inclusion criteria (3 listed)
- Those who underwent elective cesarean section over the age of 18,
- American Society of Anesthesia I and II,
- Agree to participate in the study,
Key exclusion criteria (6 listed)
- <18 or >45 years,
- preeclampsia,
- cardiovascular disorders,
- fetal abnormalities,
- not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
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 |
|---|---|---|
| perfusion indexAlso: pleth variability index, tissue hemoglobin index, tissue oxygen saturationTo compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time. | Diagnostic test | – |
Primary outcome
tissue oxygen saturation
Time frame: 4 month
which indicates an increase in local tissue perfusion
tissue hemoglobin index
Time frame: 4 month
indicating vasodilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Results publication: PubMed 22798273Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12.
- Results publication: PubMed 29034983Kuwata S, Suehiro K, Juri T, Tsujimoto S, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Pleth variability index can predict spinal anaesthesia-induced hypotension in patients undergoing caesarean delivery. Acta Anaesthesiol Scand. 2018 Jan;62(1):75-84. doi: 10.1111/aas.13012. Epub 2017 Oct 16.
- Results publication: PubMed 28890560Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.
- Individual participant dataSharing planned: No
Related trials for Postspinal Hypotension
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Postspinal Hypotension
Postspinal Hypotension
Active, not recruitingPhase 4
IV Dexamethasone in Preventing Post Spinal Hypotension
Hypotension During Surgery
RecruitingObservational study
Carotid Flow Measurements in Pregnant Women
Postspinal Hypotension, Pregnant Women Undergoing Cesarean Delivery
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.
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 Postspinal Hypotension, run by Istinye University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Feb 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue oxygen saturation (time frame: 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847737, which also lists 3 linked publications.
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 26 Feb 2025.