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Frailty and Spinal Anesthesia-Induced Hypotension in Elderly

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06757439
Enrollment
60
Registered
2025-01-03
Start date
2025-01-20
Completion date
2025-03-20
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Spinal Anesthesia

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.

Interventions

None listed

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of HypotensionPreoperative 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

MeasureTime frameDescription
Rate of BradycardiaPreoperative 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 usageDuring the procedureNecessary use of ephedrine (mg) for patients who develop hypotension
Rate of Nausea and vomitingup to 24 hoursNausea and vomiting Visual analogue scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026