What this means
This study plans to compare frail and non-frail older patients who get spinal anesthesia for surgery. It has not started recruiting, so it does not yet tell us what the results will show.
Plain-English summary written by an AI model from the registry listing.
- Status
- Opening soon
- Who can join
- Ages 65 and over · 60 patients aged 65 and older, planned
- Where
- Not listed
The science
- Registered title
- Frailty and Spinal Anesthesia-Induced Hypotension in Elderly
- Trial ID
- NCT06757439 ↗
- Phase
- Not applicable
- Study type
- observational
- Conditions
- Frailty, Spinal Anesthesia
- Sponsor
- Selcuk University
- Ages
- 65 Years to no maximum
- Dates
- First posted Jan 3, 2025 · updated Jan 3, 2025
Registry 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.