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CompletedNCT06749184Updated Nov 17, 2025

Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients

An observational study in Spinal Anesthesia-Induced Hypotension, sponsored by Konya City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Konya City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
18 Years to 80 Years
Sex
All
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Study summary

This prospective observational study aims to evaluate predictive factors for spinal anesthesia-induced hypotension (SASH) in hypertensive patients undergoing elective surgery. Parameters such as internal jugular vein collapsibility index, carotid intima-media thickness, and flow-mediated dilation will be assessed using ultrasonography to determine their association with SASH. Demographic, anthropometric, and hemodynamic data will also be analyzed. The findings may improve perioperative management strategies for hypertensive patients receiving spinal anesthesia.

Read the detailed description

This study aims to investigate the relationship between carotid intima-media thickness (CIMT) and spinal anesthesia-induced hypotension (SASH) in hypertensive patients. SASH is a common side effect of spinal anesthesia, with an incidence ranging from 15% to 33%, and is associated with significant clinical consequences such as increased morbidity and mortality. CIMT is a well-established marker of atherosclerotic burden and cardiovascular risk. This study hypothesizes that CIMT may be an independent predictor of SASH in hypertensive patients. Participants will undergo preoperative CIMT measurements and standardized spinal anesthesia procedures, with hemodynamic variables and potential risk factors recorded for analysis.

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Conditions studied

  • Spinal Anesthesia-Induced Hypotension

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Keywords

  • Spinal Anesthesia
  • Hypotension
  • Hypertensive Patients
  • Hemodynamic Predictors
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In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 110 is above the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Konya City Hospital is the lead sponsor of 76 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will include adult hypertensive patients scheduled for elective surgical procedures under spinal anesthesia at Konya City Hospital. The target population comprises patients with hypertensive patients (ASA II-III classification), who are deemed fit for elective surgery and spinal anesthesia by their clinical teams.

Eligible participants will be screened based on inclusion and exclusion criteria. The study population represents a subset of hypertensive individuals with varying durations of hypertension, medication regimens, and cardiovascular profiles. Patients will be recruited from preoperative assessment clinics and surgical wards at the hospital.

Inclusion criteria

Adult hypertensive patients classified as ASA II-III risk group. Patients scheduled for elective surgeries requiring spinal anesthesia.

Exclusion criteria

Exclusion Criteria:

Presence of severe renal or hepatic failure, or severe respiratory or cardiovascular diseases.

Contraindication to spinal anesthesia. Failure of spinal anesthesia. History of carotid surgery or presence of carotid plaques. Presence of anxiety.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Incidence of Spinal Anesthesia-Induced Hypotension (SASH)

    Percentage of patients experiencing a decrease in systolic blood pressure by 20% or more from baseline or a drop below 90 mmHg during the first 30 minutes following spinal anesthesia.

    Time frame: 30 minutes after spinal anesthesia.

Other outcomes

  1. Predictive Value of Internal Jugular Vein Collapsibility Index

    The collapsibility index of the inferior vena cava (IVC) will be measured using ultrasound. Measurements will be obtained during inspiration and expiration, and the collapsibility index will be calculated as \[(IVC diameter during expiration - IVC diameter during inspiration) / IVC diameter during expiration\] × 100%. Measurements will be performed preoperatively and 30 minutes after spinal anesthesia induction.

    Time frame: Pre-anesthesia measurement.

  2. Flow-Mediated Dilation (FMD)

    FMD will be measured using high-resolution ultrasound to assess endothelial function. Measurements will be performed on the brachial artery at baseline and after inducing hyperemia with a blood pressure cuff. FMD will be calculated as \[(post-hyperemia diameter - baseline diameter) / baseline diameter\] × 100%. The average of three repeated measurements will be recorded for analysis.

    Time frame: Pre-anesthesia measurement.

  3. Carotid Corrected Flow Time (CFTc)

    Carotid Corrected Flow Time (CFTc) will be measured using Doppler ultrasound at the common carotid artery. The uncorrected carotid flow time will be adjusted for heart rate using Bazett's formula (CFTc = observed flow time / √(R-R interval)). Measurements will be taken preoperatively and at 30 minutes after spinal anesthesia induction. The average of three consecutive measurements will be recorded.

    Time frame: Pre-anesthesia measurement.

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Study locations

1 site
  • Konya City Hospital
    Konya, Karatay 42020, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06749184
Lead sponsor
Konya City Hospital
Responsible party
Mahmut Sami TUTAR (Associate Professor, Department of Anesthesiology and Reanimation, Konya City Hospital) — Principal investigator
First posted
Dec 27, 2024
Start date
Jan 3, 2025
Primary completion
Jun 10, 2025
Completion
Jun 10, 2025
Last update
Nov 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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