Health Condition 1: O80- Encounter for full-term uncomplicated delivery
Conditions
Interventions
Intervention1: Spinal Anaesthesia: The study involves administration of 2 ml of 0.5% hyperbaric Levobupivacaine as a single-shot spinal anesthesia for cesarean section.
Dose: 2 ml of 0.5% hyperbaric L
Sponsors
Mahatma Gandhi Medical College and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Singleton uncomplicated pregnancy 2. Willing Patients
Exclusion criteria
Exclusion criteria: 1. Hypertensive disorders of pregnancy, severe valvular stenotic lesions, Deep vein thrombosis 2. Hypersensitivity to Local anesthetics 3. Anemia in Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the cardiac index between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine during spinal anesthesia for cesarean section, measured using Transthoracic Echocardiography (TTE) at predefined time points Timepoint: T0: Baseline (before spinal anesthesia) T1: Post-spinal (after achieving T4 sensory level) T2: Post-delivery. Change in cardiac index (L/min/m²) between the two groups at these time intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hemodynamic parameters Changes in mean arterial pressure (MAP), systolic and diastolic blood pressure, and heart rate at predefined time points. 2. Systemic vascular resistance surrogate Doppler Resistive Index of the descending thoracic aorta (before spinal anaesthesia, post-spinal, and post-delivery). 3. Vasopressor requirement Total number and dose of vasopressor boluses required intraoperatively. 4. Duration and quality of analgesia Time to first request for postoperative analgesia. 5. Adverse effects Incidence of hypotension, bradycardia, nausea, vomiting, pruritus, and shivering. Timepoint: 1. Real-time echocardiographic cardiac index measurement: Unlike previous studies that used pulse contour or indirect methods, our study uses transthoracic echocardiography (TTE), giving direct, objective, and accurate assessment of cardiac function. 2. Novel parameter – Resistive Index of Descending Thoracic Aorta: This serves as a surrogate for systemic vascular resistance, adding new physiological insights into maternal hemodynamic under spinal anaesthesia. 3. Clinical relevance: By directly correlating cardiac index changes with drug choice, the study could influence drug selection protocols for obstetric anaesthesia, potentially improving maternal safety. 4. Safety profile: Levobupivacaine, being the S (-) enantiomer, has lower cardiotoxicity and neurotoxicity than racemic bupivacaine, which supports its use in vulnerable populations like parturients. 5. Contribution to Indian data: Limited Indian studies have focused on real-time CI changes in caesarean section spinal anaesthesia, so our work will add valuable regional evidence | — |
Countries
India
Contacts
Public ContactRANI P
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
Outcome results
None listed