Spinal AnesthesiaNCT07789795
Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia Using the Continuous Pressure Recording Analytical Method.
A study testing Unilateral Spinal Anesthesia and Bilateral Spinal Anesthesia in people with Spinal Anesthesia and Hemodynamic Changes, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Anesthesia, Hemodynamic Changes
- What is being tested?
- Unilateral Spinal Anesthesia and Bilateral Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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. -
Who cannot join
- 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).
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- 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). -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri City Hospital
Kayseri, Kayseri
Ayşe Temiz, MD, +90 553 5369779, dr.temizayse@gmail.com
About this study
Official title: Comparison of the Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia in Hip Arthroplasty Surgeries in Elderly Patients Using the Continuous Pressure Recording Analytical Method.
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.
Read the detailed description
Hip arthroplasty is a commonly performed orthopedic procedure in elderly patients. Due to age-related physiological changes and the high prevalence of cardiovascular comorbidities, maintenance of intraoperative hemodynamic stability is essential in this population. Spinal anesthesia is widely used for lower extremity orthopedic surgery; however, sympathetic blockade may result in hypotension and impaired tissue perfusion, particularly in elderly patients.
Unilateral spinal anesthesia has been proposed as an alternative technique that may reduce the extent of sympathetic blockade and provide greater cardiovascular stability compared with conventional bilateral spinal anesthesia. Nevertheless, evidence regarding the advanced hemodynamic effects of these two techniques remains limited.
This prospective randomized controlled study aims to compare the hemodynamic effects of unilateral and bilateral spinal anesthesia in patients aged 65 years and older undergoing elective total hip arthroplasty. A total of 74 patients will be randomized to receive either unilateral spinal anesthesia (n=37) or bilateral spinal anesthesia (n=37).
Before spinal anesthesia, all participants will receive standard sedation with fentanyl (1-2 mcg/kg) and midazolam (0.015-0.03 mg/kg). Hemodynamic monitoring will be performed using the MostCare monitoring system based on the Pressure Recording Analytical Method (PRAM) through a radial arterial catheter.
The following hemodynamic parameters will be recorded at baseline, immediately after spinal anesthesia, and at predefined intraoperative time points: heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2), cardiac index (CI), stroke volume index (SVI), stroke volume variation (SVV), pulse pressure variation (PPV), systemic vascular resistance (SVR), oxygen delivery (DO2), oxygen delivery index (DO2I), maximal pressure rise during systole (dP/dtmax), cardiac cycle efficiency (CCE), and arterial elastance (Ea).
In addition, intraoperative vasopressor requirement (ephedrine use) and operative duration will be recorded and compared between study groups.
The primary objective is to determine whether unilateral spinal anesthesia provides superior hemodynamic stability compared with bilateral spinal anesthesia in elderly patients undergoing hip arthroplasty. The investigators hypothesize that unilateral spinal anesthesia will be associated with reduced hemodynamic fluctuations and lower vasopressor requirements compared with bilateral spinal anesthesia.
- Conditions
- Spinal Anesthesia, Hemodynamic Changes
- Being tested
- Unilateral Spinal Anesthesia, Bilateral Spinal Anesthesia
- Keywords
- Unilateral Spinal Anesthesia, Bilateral Spinal Anesthesia, PRAM, Hemodynamic Monitoring, Stroke Volume Variation, Pulse Pressure Variation, Vazopressor Requirement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Spinal AnesthesiaProcedure or surgery
Unilateral spinal anesthesia administered for unilateral lower extremity surgery.
Bilateral Spinal AnesthesiaProcedure or surgery
Bilateral spinal anesthesia administered for unilateral lower extremity surgery.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Spinal Anesthesia | Experimental | Patients receive unilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery. Receives: Procedure: Unilateral Spinal Anesthesia |
| Bilateral Spinal Anesthesia | Experimental | Patients receive bilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery. Receives: Procedure: Bilateral Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 May 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayşe Temiz, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789795
- Sponsor's protocol ID
- KayseriCH-AAR-AT-01
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia in Hip Arthroplasty Surgeries in Elderly Patients Using the Continuous Pressure Recording Analytical Method.
- ClinicalTrials.gov ID
- NCT07789795
- Acronym / sponsor ID
- KayseriCH-AAR-AT-01
- Conditions
- Spinal Anesthesia, Hemodynamic Changes
- Keywords
- Unilateral Spinal Anesthesia, Bilateral Spinal Anesthesia, PRAM, Hemodynamic Monitoring, Stroke Volume Variation, Pulse Pressure Variation, Vazopressor Requirement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hip arthroplasty is a commonly performed orthopedic procedure in elderly patients. Due to age-related physiological changes and the high prevalence of cardiovascular comorbidities, maintenance of intraoperative hemodynamic stability is essential in this population. Spinal anesthesia is widely used for lower extremity orthopedic surgery; however, sympathetic blockade may result in hypotension and impaired tissue perfusion, particularly in elderly patients.
Unilateral spinal anesthesia has been proposed as an alternative technique that may reduce the extent of sympathetic blockade and provide greater cardiovascular stability compared with conventional bilateral spinal anesthesia. Nevertheless, evidence regarding the advanced hemodynamic effects of these two techniques remains limited.
This prospective randomized controlled study aims to compare the hemodynamic effects of unilateral and bilateral spinal anesthesia in patients aged 65 years and older undergoing elective total hip arthroplasty. A total of 74 patients will be randomized to receive either unilateral spinal anesthesia (n=37) or bilateral spinal anesthesia (n=37).
Before spinal anesthesia, all participants will receive standard sedation with fentanyl (1-2 mcg/kg) and midazolam (0.015-0.03 mg/kg). Hemodynamic monitoring will be performed using the MostCare monitoring system based on the Pressure Recording Analytical Method (PRAM) through a radial arterial catheter.
The following hemodynamic parameters will be recorded at baseline, immediately after spinal anesthesia, and at predefined intraoperative time points: heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2), cardiac index (CI), stroke volume index (SVI), stroke volume variation (SVV), pulse pressure variation (PPV), systemic vascular resistance (SVR), oxygen delivery (DO2), oxygen delivery index (DO2I), maximal pressure rise during systole (dP/dtmax), cardiac cycle efficiency (CCE), and arterial elastance (Ea).
In addition, intraoperative vasopressor requirement (ephedrine use) and operative duration will be recorded and compared between study groups.
The primary objective is to determine whether unilateral spinal anesthesia provides superior hemodynamic stability compared with bilateral spinal anesthesia in elderly patients undergoing hip arthroplasty. The investigators hypothesize that unilateral spinal anesthesia will be associated with reduced hemodynamic fluctuations and lower vasopressor requirements compared with bilateral spinal anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Spinal Anesthesia | Experimental | Procedure: Unilateral Spinal AnesthesiaPatients receive unilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery. |
| Bilateral Spinal Anesthesia | Experimental | Procedure: Bilateral Spinal AnesthesiaPatients receive bilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Spinal AnesthesiaUnilateral spinal anesthesia administered for unilateral lower extremity surgery. | Procedure or surgery | Unilateral Spinal Anesthesia |
| Bilateral Spinal AnesthesiaBilateral spinal anesthesia administered for unilateral lower extremity surgery. | Procedure or surgery | Bilateral Spinal Anesthesia |
Primary outcome
Cardiac Index Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Stroke Volume Index Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Stroke Volume Variation Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Pulse Pressure Variation Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Systemic Vascular Resistance Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Oxygen Delivery Index Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Arterial Elastance Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Maximum Rate of Arterial Pressure Rise Measured Using PRAM
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Cardiac Cycle Efficiency Measured Using PRAM
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Oxygen Delivery Measured Using PRAM During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Mean Arterial Pressure During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Heart Rate During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Peripheral Oxygen Saturation During Spinal Anesthesia
Time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Spinal Anesthesia and Bilateral Spinal Anesthesia in people with Spinal Anesthesia and Hemodynamic Changes, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Index Measured Using PRAM During Spinal Anesthesia (time frame: From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.