Ultrasound Assessment of Femoral Vein and Inferior Vena Cava Collapsibility to Predict Spinal Anesthesia-Induced Hypotension

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-75
SponsorAntalya Training and Research Hospital

About this trial

Spinal anesthesia is commonly used in transurethral prostate resection (TUR-P) surgeries; however, post-spinal hypotension remains a frequent and clinically significant complication, particularly in elderly patients. Early prediction of hypotension may allow timely interventions and improve patient safety.

This prospective observational study aims to evaluate the predictive value of preoperative ultrasound-based inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for post-spinal hypotension in patients undergoing elective TUR-P under spinal anesthesia. Before spinal anesthesia, IVC and femoral vein measurements will be obtained using ultrasonography. Hemodynamic parameters will be recorded before and after spinal anesthesia, and the occurrence of hypotension will be assessed according to predefined criteria.

The study seeks to compare the diagnostic performance of IVC-CI and FVCI in predicting post-spinal hypotension and to identify potential clinical predictors associated with hypotension in this patient population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18-75 years

American Society of Anesthesiologists (ASA) physical status I-III

Scheduled for elective transurethral resection of the prostate (TUR-P)

Planned spinal anesthesia

Disqualifiers

Refusal to participate in the study

Body mass index (BMI) >30 kg/m²

Use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers

Emergency surgery

Trial population

The study population consists of adult male patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective transurethral resection of the prostate (TUR-P) under spinal anesthesia. All participants will be recruited from a single tertiary care center. Patients will be evaluated preoperatively, and eligible individuals who provide written informed consent will be included in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 2 trial groups
Group A: Post-Spinal Hypotension Group
Group B: Non-Hypotension Group

Trial outcomes

Primary outcomes

1

Prediction of Post-Spinal Hypotension Using Inferior Vena Cava and Femoral Vein Collapsibility Indices

The primary outcome is the predictive value of the inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for the development of post-spinal hypotension. Hypotension is defined as a systolic blood pressure \<90 mmHg, a decrease in systolic blood pressure \>30% from baseline, or a mean arterial pressure \<60 mmHg within 15 minutes after spinal anesthesia.

Time frame
Within the first 15 minutes after spinal anesthesia

Secondary outcomes

1

Comparison of Diagnostic Performance of IVC-CI and FVCI for Post-Spinal Hypotension

Comparison of the diagnostic performance of inferior vena cava collapsibility index (IVC-CI) and femoral vein collapsibility index (FVCI) for predicting post-spinal hypotension using predefined hypotension criteria.

Time frame
Within the first 15 minutes after spinal anesthesia

Other outcomes

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