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NCT Number: NCT06749184

Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients

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.

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Key information

Conditions

Spinal Anesthesia-Induced Hypotension Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 30 minutes after spinal anesthesia.

    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.

Other outcomes

  1. Predictive Value of Internal Jugular Vein Collapsibility Index

    Time frame: Pre-anesthesia measurement.

    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.

  2. Flow-Mediated Dilation (FMD)

    Time frame: Pre-anesthesia measurement.

    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.

  3. Carotid Corrected Flow Time (CFTc)

    Time frame: Pre-anesthesia measurement.

    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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Determining Factors That Predict Hypotension Related to Spinal Anesthesia in Patients With Hypertension

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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