Clinical trial NCT06749184: Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients
Official title: Determining Factors That Predict Hypotension Related to Spinal Anesthesia in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia-Induced Hypotension
Keywords: Spinal Anesthesia
Hypotension
Hypertensive Patients
Hemodynamic Predictors
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 controlled hypertension (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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Spinal Anesthesia-Induced Hypotension (SASH)
timeFrame: 30 minutes after spinal anesthesia.
Secondary outcomes:
Other outcomes:
measure: Predictive Value of Internal Jugular Vein Collapsibility Index
timeFrame: Pre-anesthesia measurement.
measure: Flow-Mediated Dilation (FMD)
timeFrame: Pre-anesthesia measurement.
measure: Carotid Corrected Flow Time (CFTc)
timeFrame: Pre-anesthesia measurement.
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
state: Karatay
Study officials:
References: