Postspinal HypotensionNCT07765342
Diastolic Shock Index for Predicting Postspinal Hypotension
An observational study of Postspinal Hypotension, run by Istinye University.
Trial summary
This prospective observational study aims to evaluate the diagnostic performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare its performance with other shock indices, including the Shock Index, Modified Shock Index, and Age Shock Index. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Postspinal Hypotension
- What is being tested?
- Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 21 Aug 2026to 7 Mar 2027
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients aged 50 years and older who are scheduled to undergo elective unilateral inguinal hernia surgery under spinal anesthesia at the University of Health Sciences Haseki Training and Research Hospital. Eligible patients with American Society of Anesthesiologists physical status I-III who provide written informed consent will be included. A minimum of 85 patients is planned for enrollment.
Who may be able to join
- Age 50 years or older
- Scheduled for elective unilateral inguinal hernia surgery
- Scheduled to undergo surgery under spinal anesthesia
- American Society of Anesthesiologists physical status I-III
- Provision of written informed consent
Who cannot join
- Refusal to participate in the study
- Emergency surgery
- Bilateral inguinal hernia surgery
- Contraindication to spinal anesthesia
- Failure of spinal anesthesia or conversion to general anesthesia due to failed spinal block
- Requirement for additional general anesthesia or deep sedation during surgery
Show all 16Show fewer
- Operation duration exceeding 120 minutes
- Atrial fibrillation, atrial flutter, frequent ventricular ectopy, or other arrhythmias preventing reliable heart rate assessment
- Presence of a permanent cardiac pacemaker
- Severe valvular heart disease
- New York Heart Association class III-IV heart failure
- Preoperative use of vasopressor or inotropic therapy
- Severe hepatic failure or end-stage renal disease
- Neurological disease that may significantly affect autonomic nervous system function
- Preoperative hemodynamic instability, defined as systolic arterial pressure <90 mmHg or >180 mmHg, or heart rate <50 or >120 beats/min
- Missing study data or inability to obtain records in accordance with the study protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Diagnostic Performance of the Diastolic Shock Index and Other Shock Indices in Predicting Postspinal Hypotension
This prospective observational study aims to evaluate the diagnostic performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare its performance with other shock indices, including the Shock Index, Modified Shock Index, and Age Shock Index. The study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. Hemodynamic parameters will be recorded before and after spinal anesthesia as part of routine clinical monitoring. The primary outcome is the development of postspinal hypotension. Secondary outcomes include vasopressor requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated shock indices using receiver operating characteristic curve analysis. No additional intervention beyond routine anesthetic and perioperative care will be performed for study purposes.
Read the detailed description
This prospective observational study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. The study aims to evaluate the performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare it with the Shock Index, Modified Shock Index, and Age Shock Index. Baseline systolic, diastolic, and mean arterial pressures and heart rate will be recorded before spinal anesthesia and used to calculate the four shock indices. Hemodynamic parameters will also be recorded at 5, 10, 15, and 20 minutes after spinal anesthesia as part of routine clinical monitoring, without any additional intervention for research purposes.Postspinal hypotension will be defined as a decrease in systolic arterial pressure of at least 25% from baseline and/or a systolic arterial pressure below 90 mmHg. The primary outcome will be postspinal hypotension, while secondary outcomes will include ephedrine requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated indices. Receiver operating characteristic curve analysis will be used to compare the indices and determine the optimal cut-off value for the Diastolic Shock Index, with a minimum of 85 patients planned for inclusion.
- Conditions
- Postspinal Hypotension
- Being tested
- Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
Spinal anesthesia will be administered as part of routine clinical care for elective unilateral inguinal hernia surgery. The study will not modify the anesthetic management or introduce any additional intervention for research purposes. Hemodynamic parameters obtained during routine perioperative monitoring will be recorded to evaluate the development of postspinal hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Patients Who Develop Postspinal Hypotension | Patients who develop postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia. Receives: Procedure: Spinal Anesthesia | |
| Patients Who Do Not Develop Postspinal Hypotension | Patients who do not develop postspinal hypotension, defined as the absence of a decrease in systolic arterial pressure of 25% or more from baseline and a systolic arterial pressure remaining at or above 90 mmHg following spinal anesthesia. Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Postspinal Hypotension
Occurrence of postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.
Measured: Within the first 20 minutes 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 posted14 Aug 2026
- Study start21 Aug 2026 (estimated)
- Primary completion21 Feb 2027 (estimated)
- Study completion7 Mar 2027 (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.
- 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
- 85 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
- NCT07765342
- Sponsor's protocol ID
- şilan tez
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PubMed 30236233Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vasquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
PubMed 29189290Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
PubMed 1599111
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Performance of the Diastolic Shock Index and Other Shock Indices in Predicting Postspinal Hypotension
- ClinicalTrials.gov ID
- NCT07765342
- Acronym / sponsor ID
- şilan tez
- Conditions
- Postspinal Hypotension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- 21 Feb 2027 (estimated)
- Study completion
- 7 Mar 2027 (estimated)
- First posted
- 14 Aug 2026 (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.
This prospective observational study aims to evaluate the diagnostic performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare its performance with other shock indices, including the Shock Index, Modified Shock Index, and Age Shock Index. The study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. Hemodynamic parameters will be recorded before and after spinal anesthesia as part of routine clinical monitoring. The primary outcome is the development of postspinal hypotension. Secondary outcomes include vasopressor requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated shock indices using receiver operating characteristic curve analysis. No additional intervention beyond routine anesthetic and perioperative care will be performed for study purposes.
Detailed description
This prospective observational study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. The study aims to evaluate the performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare it with the Shock Index, Modified Shock Index, and Age Shock Index. Baseline systolic, diastolic, and mean arterial pressures and heart rate will be recorded before spinal anesthesia and used to calculate the four shock indices. Hemodynamic parameters will also be recorded at 5, 10, 15, and 20 minutes after spinal anesthesia as part of routine clinical monitoring, without any additional intervention for research purposes.Postspinal hypotension will be defined as a decrease in systolic arterial pressure of at least 25% from baseline and/or a systolic arterial pressure below 90 mmHg. The primary outcome will be postspinal hypotension, while secondary outcomes will include ephedrine requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated indices. Receiver operating characteristic curve analysis will be used to compare the indices and determine the optimal cut-off value for the Diastolic Shock Index, with a minimum of 85 patients planned for inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Who Develop Postspinal Hypotension | – | Procedure: Spinal AnesthesiaPatients who develop postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia. |
| Patients Who Do Not Develop Postspinal Hypotension | – | Procedure: Spinal AnesthesiaPatients who do not develop postspinal hypotension, defined as the absence of a decrease in systolic arterial pressure of 25% or more from baseline and a systolic arterial pressure remaining at or above 90 mmHg following spinal anesthesia. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients aged 50 years and older who are scheduled to undergo elective unilateral inguinal hernia surgery under spinal anesthesia at the University of Health Sciences Haseki Training and Research Hospital. Eligible patients with American Society of Anesthesiologists physical status I-III who provide written informed consent will be included. A minimum of 85 patients is planned for enrollment.
Key inclusion criteria (5 listed)
- Age 50 years or older
- Scheduled for elective unilateral inguinal hernia surgery
- Scheduled to undergo surgery under spinal anesthesia
- American Society of Anesthesiologists physical status I-III
- Provision of written informed consent
Key exclusion criteria (16 listed)
- Refusal to participate in the study
- Emergency surgery
- Bilateral inguinal hernia surgery
- Contraindication to spinal anesthesia
- Failure of spinal anesthesia or conversion to general anesthesia due to failed spinal block
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 |
|---|---|---|
| Spinal AnesthesiaSpinal anesthesia will be administered as part of routine clinical care for elective unilateral inguinal hernia surgery. The study will not modify the anesthetic management or introduce any additional intervention for research purposes. Hemodynamic parameters obtained during routine perioperative monitoring will be recorded to evaluate the development of postspinal hypotension. | Procedure or surgery | Patients Who Develop Postspinal Hypotension, Patients Who Do Not Develop Postspinal Hypotension |
Primary outcome
Development of Postspinal Hypotension
Time frame: Within the first 20 minutes after spinal anesthesia
Occurrence of postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.
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 14 Aug 2026.
- Results publication: PubMed 30236233Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
- Results publication: PubMed 29189290Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vasquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
- Results publication: PubMed 1599111Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Postspinal Hypotension
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Postspinal Hypotension, run by Istinye University.
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 5 inclusion and 16 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 dolğun (5555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Postspinal Hypotension (time frame: Within the first 20 minutes after spinal anesthesia). 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 NCT07765342, 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 14 Aug 2026.