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Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia Using the Continuous Pressure Recording Analytical Method.

RecruitingNAAges 65 Years - anyAllKayseri City Hospital
NCT07789795 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled study aims to compare the intraoperative hemodynamic effects of unilateral and bilateral spinal anesthesia in elderly patients undergoing elective total hip arthroplasty. Seventy-four patients aged 65 years and older will be randomized into two groups: unilateral spinal anesthesia (n=37) and bilateral spinal anesthesia (n=37). Hemodynamic parameters including cardiac output, stroke volume, stroke volume variation, pulse pressure variation, and systemic vascular resistance will be continuously monitored using the Pressure Recording Analytical Method (PRAM)-based MostCare monitoring system. Intraoperative fluid requirements and vasopressor consumption will also be evaluated. The study seeks to determine whether unilateral spinal anesthesia provides greater hemodynamic stability and reduces the need for fluid administration and vasopressor support compared with

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged 65 years and older. 2. Patients scheduled for elective total hip arthroplasty. 3. Patients with an American Society of Anesthesiologists (ASA) physical status classification of II, III, or IV. 4. Patients with a Glasgow Coma Scale (GCS) score of 13-15 who are conscious and able to cooperate. 5. Patients with suitable peripheral arterial anatomy for PRAM monitoring. 6. Patients who provide written informed consent to participate in the study. 7. Patients without any clinical contraindication to spinal anesthesia. - Exclusion Criteria: 1. Glasgow Coma Scale (GCS) score \<13. 2. Age below 65 years. 3. History of previous major neurosurgical intervention. 4. Anatomical abnormality, vascular defect, or infection at the site intended for arterial catheter placement for PRAM monitoring. 5. Severe spinal deformity (e.g., severe scoliosis, previous spinal fusion surgery, or spinal trauma). 6. Current anticoagulant therapy or coagulopathy (INR \>1.5 or platelet count \<75,000/mm³). 7. Presence of skin infection or systemic infection/sepsis. 8. Severe hypovolemia or decompensated cardiac disease in which spinal anesthesia is contraindicated. 9. Known allergy or hypersensitivity to local anesthetics or sedative agents. 10. Local infection or wound at the planned spinal puncture site. 11. Clinical contraindication to spinal anesthesia (e.g., increased intracranial pressure, septicemia, or severe hypotension). -
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What it tests

  • Unilateral Spinal Anesthesia
  • Bilateral Spinal Anesthesia
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Where

1 site
Kayseri City Hospital
Kayseri, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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