A comparative evaluation of intrathecal hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% for elective cesarean section : A prospective randomised study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- A COMPARATIVE EVALUATION OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE 0.5% WITH HYPERBARIC BUPIVACAINE 0.5% FOR ELECTIVE CESAREAN SECTION
研究概览
简要总结
Spinal Anesthesia is accepted as a safe technique for cesarean section worldwide. With the increasing number of cesarean section under spinal anesthesia various local anesthetic agents are being studied for their efficacy, hemodynamic stability and other effects . Hyperbaric bupivacaine is most commonly used local anesthetic agent in elective cesarean section.
Bupivacaine is racemic mixture of dextro and levo and provides dense sensory and motor block which may lead to prolonged immobilization and hypotension.
Enantiomers may have the same desired pharmacological properties but fewer side effects. Levobupivacaine , the s enantiomer has shown to provide a more selective neuraxial blockade than racemic bupivacaine.
Hyperbaric levobupivacaine was commercially not available previously but as of now, hyperbaric solutions are available in India . The claimed benifits of these agents have reduced cardiac toxicity and more specific effects on sensory rather than motor nerve fibers . The decreased toxicity of levobupivacaine is attributed to it faster binding rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant Females between age 18 to 40 years.
- •Patients belonging to ASA grade 1 and
- •Subjects willing to sign informed consent for participation in study.
排除标准
- •Patients under going caesearian section for fetal distress and hypertensive disorders of pregnancy.
- •Known allergy to the study drug
- •History of Liver, Renal & Cardiac diseases.
- •BMI > 30 5.Height <150cm and >180cm.
结局指标
主要结局
A COMPARATIVE EVALUATION OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE 0.5% WITH HYPERBARIC BUPIVACAINE 0.5% FOR ELECTIVE CESAREAN SECTION
时间窗: 1.ONSET OF SENSORY BLOCK | 2.MAXIMUM HEIGHT OF SENSORY BLOCK | 3.DURATION OF SENSORY BLOCK | 4.ONSET OF MOTOR BLOCK | 5.DURATION OF MOTOR BLOCK
次要结局
- Hemodynamic parameters (Heart Rate and Mean Arterial Pressure).(Side effects like nausea, vomiting, bradycardia and Hypotension.)