Clinical Trial

Frailty and Spinal Anesthesia-Induced Hypotension in Elderly

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Record status
This record was last updated January 3, 2025 (before its estimated March 20, 2025 completion). Its status may not reflect the trial's current state.
Summary
60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study. Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Frailty assessments will be performed using the Clinical Frailty Scale (CFS) version 2.0 by anesthesiologists in preoperative clinics or wards. Participants will be categorized into frail (CFS Level ≥4, Group I) and non-frail (CFS Level ≤3, Group II) groups. Prior to spinal anesthesia, 8 mL/kg of crystalloids will be administered. Baseline preoperative mean arterial blood pressure (MABP) and heart rate (HR) will be recorded as the average of three measurements in the supine position. During the study, MABP and HR will be monitored every 2 minutes for the first 20 minutes post-spinal anesthesia, then every 5 minutes until surgery ends. Hypotension (MABP \<80% of baseline) will be treated with 5 mg intravenous ephedrine, while bradycardia (HR \<50 beats/min) will be treated with 0.5 mg intravenous atropine.
Trial Details
NCT Number NCT06757439
Lead Sponsor Selcuk University
Conditions Frailty, Spinal Anesthesia
Enrollment 60 participants
Start Date 2025-01-20
Primary Completion 2025-03-20 (estimated)
Study Completion 2025-03-20 (estimated)
Updated on ClinicalTrials.gov 2025-01-03