Frailty and Spinal Anesthesia-Induced Hypotension in Elderly

Effect of Frailty on Spinal Anesthesia-induced Hypotension in Geriatric Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Spinal Anesthesia

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male and female patients aged 65 and over

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Frail; CFS Level ≥4
Non-frail; CFS Level ≤3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Frailty; Hypotension
• Other Study ID Numbers: 2024-12-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No