跳至主要内容
临床试验/CTRI/2025/11/097259
CTRI/2025/11/097259尚未招募不适用

Effect of Hyperbaric Levobupivacaine and Bupivacaine on Realtime Cardiac index during Spinal Anesthesia for Cesarean Section A Randomized Control Study

Mahatma Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
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

研究概览

简要总结

This prospective randomized controlled study is designed to compare the effects of 0.5% hyperbaric levobupivacaine and hyperbaric bupivacaine on maternal hemodynamic during spinal anaesthesia for elective caesarean section the primary focus is on real time cardiac index measure using transthoracic echocardiography along with assessment of mean arterial pressure systemic vascular resistance vasopressor requirements and side effects

Spinal anaesthesia though a preferred for caesarean sections is often complicated by maternal hypotension and reduced cardiac output levobupivacaine the s enantiomer of bupivacaine offers a safer pharmacological profile with reduced cardiotoxicity and better hemodynamic stability this study aims to objectively quantify these differences using echocardiographic parameters providing more accurate insights than earlier studies that used indirect monitoring

It is hypothesized that levobupivacaine will better preserve cardiac index and came less hypotension compared to bupivacaine to bupivacaine thereby reducing vasopressor use and improving maternal safety Findings from this trial may help optimize anesthetic drug selection in obstetric practice ensuring safer perioperative management for mothers  and neonates

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Singleton uncomplicated pregnancy
  • Willing Patients.

排除标准

  • Hypertensive disorders of pregnancy, severe valvular stenotic lesions, Deep vein thrombosis
  • Hypersensitivity to Local anesthetics
  • Anemia in Pregnancy.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 1. Hemodynamic parameters(Changes in mean arterial pressure (MAP), systolic and diastolic blood pressure, and heart rate at predefined time points.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

BASKAR C

MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE

研究点 (1)

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