Frailty and Spinal Anesthesia-Induced Hypotension in Elderly

Not yet recruiting

• Conditions: Frailty; Spinal Anesthesia

• Registration Number: NCT06757439
• Lead Sponsor: Selcuk University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-19
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Study Start: 2025-01-20
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 65 and older
• ASA I-III physical status
• Undergoing elective surgery under spinal anesthesia

Exclusion Criteria

• Patients with cardiac arrhythmia
• Patients with severe heart failure
• Patients with cerebrovascular disease
• Contraindications to neuraxial anesthesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Hypotension	Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.	Hypotension, defined as MABP below 80% of baseline values

Secondary Outcome Measures

Name	Time	Method
Rate of Bradycardia	Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.	Bradycardia defined as HR \<50 beats/min
Ephedrine usage	During the procedure	Necessary use of ephedrine (mg) for patients who develop hypotension
Rate of Nausea and vomiting	up to 24 hours	Nausea and vomiting Visual analogue scale