Frailty and Spinal Anesthesia-Induced Hypotension in Elderly
NCT ID: NCT06757439
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2025-01-20
2025-03-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Frail
CFS Level ≥4
No interventions assigned to this group
Non-frail
CFS Level ≤3
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ASA I-III physical status
* Undergoing elective surgery under spinal anesthesia
Exclusion Criteria
* Patients with severe heart failure
* Patients with cerebrovascular disease
* Contraindications to neuraxial anesthesia
65 Years
ALL
No
Sponsors
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Selcuk University
OTHER
Responsible Party
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Mehmet SARGIN
Associate Professor
Other Identifiers
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2024-12-1
Identifier Type: -
Identifier Source: org_study_id
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