CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06871449
NCT06871449N/ACompleted

Investigation Of The Effects Of Unilateral And Bilateral Spinal Anesthesia On Cerebral Blood Flow

Nuh Naci Yazgan University·observational·Posted Mar 12, 2025·Updated Mar 12, 2025

In Brief

An observational study for Adverse Effect and Cerebral Perfusion. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Spinal anesthesia is a widely used method in anesthesia practice. Unilateral spinal block refers to a neuroaxial technique that induces motor and sensory blockade on the surgical side. While spinal anesthesia offers numerous advantages, it is associated with complications such as hypotension, headache, transient neurological symptoms, and meningitis. Among these, hypotension is the most common. To mitigate hemodynamic issues, intravenous fluid preloading and vasopressor use are standard practices in many centers. This study aimed to compare regional cerebral oxygenation (rSO₂) values in patients undergoing unilateral and bilateral spinal blocks to identify the least complicated and most effective method. Minimizing complications can facilitate early mobilization, reduce hospital stays, and lower infection risks. The study included 60 male patients (aged 18-65 years) scheduled for unilateral inguinal hernia surgery at Kayseri City Hospital. Inclusion criteria were the absence of coagulation disorders, infections, or systemic diseases, hemoglobin levels \>10 g/dL, and BMI \<30. Patients were randomized into two groups: Group I: Unilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in a lateral position on the surgical side for 5 minutes, then moved to the supine position. Group II: Bilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in the supine position for 5 minutes. Sensory block levels were assessed using the pin-prick test, and motor blocks were evaluated with the Bromage scale. Surgery commenced when the sensory block reached the T10 level. Patient data, including age, BMI, hemoglobin, baseline systolic/diastolic blood pressure (SBP/DBP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO₂), and rSO₂, were recorded before and after spinal anesthesia. SBP, DBP, MAP, HR, SpO₂, and rSO₂ values were monitored at 5-minute intervals for 30 minutes.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 12, 2025
Enrollment StartMar 27, 2022
Primary CompletionNov 29, 2022
Study CompletionMar 27, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 1.3 years ago