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NCT Number: NCT06757439

Frailty and Spinal Anesthesia-Induced Hypotension in Elderly

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Anesthesia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of Hypotension

    Time frame: 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 outcomes

  1. Rate of Bradycardia

    Time frame: 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

  2. Ephedrine usage

    Time frame: During the procedure

    Necessary use of ephedrine (mg) for patients who develop hypotension

  3. Rate of Nausea and vomiting

    Time frame: up to 24 hours

    Nausea and vomiting Visual analogue scale

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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