Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients

NCT06749184 | Completed

• 1 other identifier: 3.05.2024-27769
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia-Induced Hypotension

Keywords

Spinal Anesthesia; Hypotension; Hypertensive Patients; Hemodynamic Predictors

Outcome Measures

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.

  30 minutes after spinal anesthesia.

Other Outcomes (3)

• Predictive Value of Internal Jugular Vein Collapsibility Index

  Pre-anesthesia measurement.

• Flow-Mediated Dilation (FMD)

  Pre-anesthesia measurement.

• Carotid Corrected Flow Time (CFTc)

  Pre-anesthesia measurement.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 3, 2025
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)