Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia Using the Continuous Pressure Recording Analytical Method.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorKayseri City Hospital

About this trial

This randomized controlled study aims to compare the intraoperative hemodynamic effects of unilateral and bilateral spinal anesthesia in elderly patients undergoing elective total hip arthroplasty. Seventy-four patients aged 65 years and older will be randomized into two groups: unilateral spinal anesthesia (n=37) and bilateral spinal anesthesia (n=37).

Hemodynamic parameters including cardiac output, stroke volume, stroke volume variation, pulse pressure variation, and systemic vascular resistance will be continuously monitored using the Pressure Recording Analytical Method (PRAM)-based MostCare monitoring system. Intraoperative fluid requirements and vasopressor consumption will also be evaluated.

The study seeks to determine whether unilateral spinal anesthesia provides greater hemodynamic stability and reduces the need for fluid administration and vasopressor support compared with conventional bilateral spinal anesthesia in elderly patients undergoing hip arthroplasty.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 65 years and older.

Patients scheduled for elective total hip arthroplasty.

Patients with an American Society of Anesthesiologists (ASA) physical status classification of II, III, or IV.

Patients with a Glasgow Coma Scale (GCS) score of 13-15 who are conscious and able to cooperate.

Disqualifiers

Glasgow Coma Scale (GCS) score <13.

Age below 65 years.

History of previous major neurosurgical intervention.

Anatomical abnormality, vascular defect, or infection at the site intended for arterial catheter placement for PRAM monitoring.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unilateral Spinal Anesthesia

    Procedure/Surgery

    Unilateral spinal anesthesia administered for unilateral lower extremity surgery.

  • Bilateral Spinal Anesthesia

    Procedure/Surgery

    Bilateral spinal anesthesia administered for unilateral lower extremity surgery.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Unilateral Spinal AnesthesiaExperimental treatment 1 intervention
Group B: Bilateral Spinal AnesthesiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cardiac Index Measured Using PRAM During Spinal Anesthesia

Cardiac index will be measured using the Pressure Recording Analytical Method (PRAM) and reported in L/min/m². Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

Time frame
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
2

Stroke Volume Index Measured Using PRAM During Spinal Anesthesia

Stroke volume index will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mL/beat/m². Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

Time frame
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
3

Stroke Volume Variation Measured Using PRAM During Spinal Anesthesia

Stroke volume variation will be measured using the Pressure Recording Analytical Method (PRAM) and reported as a percentage. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

Time frame
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
4

Pulse Pressure Variation Measured Using PRAM During Spinal Anesthesia

Pulse pressure variation will be measured using the Pressure Recording Analytical Method (PRAM) and reported as a percentage. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

Time frame
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.

Secondary outcomes

Other outcomes

Sponsors and contacts

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