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

NCT07789795 | Recruiting

• 1 other identifier: KayseriCH-AAR-AT-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anesthesia; Hemodynamic Changes

Keywords

Unilateral Spinal Anesthesia; Bilateral Spinal Anesthesia; PRAM; Hemodynamic Monitoring; Stroke Volume Variation; Pulse Pressure Variation; Vazopressor Requirement

Outcome Measures

Primary Outcomes (13)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Systemic Vascular Resistance Measured Using PRAM During Spinal Anesthesia

  Systemic vascular resistance will be measured using the Pressure Recording Analytical Method (PRAM) and reported in dyn·s/cm⁵. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

• Oxygen Delivery Index Measured Using PRAM During Spinal Anesthesia

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

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

• Arterial Elastance Measured Using PRAM During Spinal Anesthesia

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

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

• Maximum Rate of Arterial Pressure Rise Measured Using PRAM

  The maximum rate of arterial pressure rise (dP/dtmax) will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mmHg/s. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

• Cardiac Cycle Efficiency Measured Using PRAM

  Cardiac cycle efficiency (CCE) will be measured using the Pressure Recording Analytical Method (PRAM) and reported as a dimensionless value. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

• Oxygen Delivery Measured Using PRAM During Spinal Anesthesia

  Oxygen delivery (DO₂) will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mL/min. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

• Mean Arterial Pressure During Spinal Anesthesia

  Mean arterial pressure (MAP) will be measured using invasive arterial pressure monitoring and reported in mmHg. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

• Heart Rate During Spinal Anesthesia

  Heart rate (HR) will be recorded using standard perioperative monitoring and reported in beats per minute. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

• Peripheral Oxygen Saturation During Spinal Anesthesia

  Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.

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

Study Arms (2)

Unilateral Spinal Anesthesia

EXPERIMENTAL

Patients receive unilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery.

Procedure: Unilateral Spinal Anesthesia

Bilateral Spinal Anesthesia

EXPERIMENTAL

Patients receive bilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery.

Procedure: Bilateral Spinal Anesthesia

Interventions

Unilateral Spinal Anesthesia PROCEDURE

Unilateral spinal anesthesia administered for unilateral lower extremity surgery.

Unilateral Spinal Anesthesia

Bilateral Spinal Anesthesia PROCEDURE

Bilateral spinal anesthesia administered for unilateral lower extremity surgery.

Bilateral Spinal Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Patients with suitable peripheral arterial anatomy for PRAM monitoring.
• Patients who provide written informed consent to participate in the study.
• Patients without any clinical contraindication to spinal anesthesia. -

You may not qualify if:

• 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.
• Severe spinal deformity (e.g., severe scoliosis, previous spinal fusion surgery, or spinal trauma).
• Current anticoagulant therapy or coagulopathy (INR \>1.5 or platelet count \<75,000/mm³).
• Presence of skin infection or systemic infection/sepsis.
• Severe hypovolemia or decompensated cardiac disease in which spinal anesthesia is contraindicated.
• Known allergy or hypersensitivity to local anesthetics or sedative agents.
• Local infection or wound at the planned spinal puncture site.
• Clinical contraindication to spinal anesthesia (e.g., increased intracranial pressure, septicemia, or severe hypotension). -

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident physician

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: August 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)