Comparison of height adjusted dose versus fixed dose of 0.5% hyperbaric bupivacaine in spinal anaesthesia for caesarean delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare the incidence of hypotension, in parturients receiving height adjusted dose and fixed dose of 0.5% hyperbaric bupivacaine under spinal anaesthesia for caesarean delivery
研究概览
简要总结
This prospective, randomized, comparative, double-blind study will be conducted after obtaining approval from the Institutional Ethical and Scientific Committee of Deen Dayal Upadhyay Hospital and written informed consent of patients. One hundred and ten patients fulfilling the inclusion criteria, scheduled for elective or emergency caesarean delivery under spinal anaesthesia, will be enrolled in the study. Patients will be allocated to one of the two study groups after randomization. Patients in Group H will receive height adjusted dose (0.06 mg/ cm height) of 0.5% bupivacaine heavy with 10µg fentanyl and patients in Group F will receive 2 ml (10mg) of 0.5% bupivacaine heavy with 10µg fentanyl for spinal anaesthesia. Following study drug injection, the incidence of hypotension,dose of inj. mephentermine used, sensory and motor block characteristics, incidence of complications such as bradycardia, nausea and vomiting and neonatal outcome (Apgar score) will be compared in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anesthesiologists physical status I or II women with term pregnancy (> 37 weeks gestation), with singleton pregnancy, with Height between 140 cm to 170 cm (both values inclusive) and Weight between 40 kg to 90 kg (both values inclusive).
排除标准
- •1.Patient refusal 2.Pre-existing or pregnancy induced hypertension 3.Diabetes Mellitus, cardiovascular or cerebrovascular disease 4.Spine deformities or history of spine surgery 5.Foetal abnormality, fetal distress, complicated pregnancy 6.Allergy to any study medication 7.Absolute or relative contraindication to spinal anaesthesia.
结局指标
主要结局
To compare the incidence of hypotension, in parturients receiving height adjusted dose and fixed dose of 0.5% hyperbaric bupivacaine under spinal anaesthesia for caesarean delivery
时间窗: injection of spinal anaesthetic drug till the end of surgery
次要结局
- Sensory block characteristics(injection of spinal anaesthetic drug till regression of sensory block to S2 dermatome.)
- Motor block characteristics
- Total dose of Injection mephentermine used to treat hypotension(injection of spinal anaesthetic drug till complete motor (muscle power)recovery)
- Incidence of bradycardia, nausea, vomiting(injection of spinal anaesthetic drug till complete motor (muscle power)recovery)
- Neonatal outcome (Apgar score)(Apgar score at 1 minute and 5 minute post delivery of baby)