Comparison of efficacy of fractionated versus single bolus dose of spinal anaesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries: A prospective randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the onset, peak and duration of sensory and motor block in fractionated and single bolus dose of spinal anesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries.
研究概览
简要总结
Afterethical committee approval and informed consent, patients will be recruited forthe study. Preoperative evaluation is doneand the subjects will be randomized via computergenerated table and allocated to one ofthe groups. Group B: 3.6 ml of 0.5% hyperbaric Bupivacaine,Group F : 3.6 ml of 0.5% hyperbaric Bupivacaine in fractionatedapproach. Demographic details (Age,sex, weight, ASA status, height) will be noted.
Asa standard practice, pre-operatively patients will be kept fasting for 6 hours.They will be routinely premedicated with Tab. Alprazolam 0.5 mg and Tab.Pantoprazole 40 mg on the night prior to surgery and on the morning ofsurgery.
Intraoperativelypatients will be monitored by electrocardiography, non-invasive blood pressureand pulse oximetry. In group B - Spinalanesthesia will be given with 3.6cc of 0.5% heavy Bupivacaine at L3-4interspace via 25 G spinal needle, with subject in the sitting position . In group F - Spinalanesthesia of 3.6cc of 0.5% heavyBupivacaine at L3-4 interspace via 25 G spinal needle will be given in afractionated approach where 2.4cc(2/3rd) will be given first andthen the remaining 1.2ml (1/3rd) will be given after 120sec.Thesubject will made to lie supinesoon after the injection. At 5 mins after theinjection, level of block –sensory by pinprick and motor by bromage scale willbe checked. This will be considered asonset of sensory and motor block. At20min, the peak level of sensory and motor block willalso be noted.
Theduration of spinal anesthesia is considered as two segment regression from the level of sensory block achieved at 20min(peak) of sensory block . At the endof surgery, both the sensory level and motor block will be rechecked. Vitalssuch as Heart rate (HR), Systolic blood pressure (SBP), Diastolicblood pressure (DBP), Mean arterial blood pressure (MAP), saturation (SpO2)will be measured at every 5 mins for 1sthourand then 10min till the end of surgery.
Anyside effects of the spinal anesthesia such as: Bradycardia (HR < 20% ofbaseline), Hypotension (BP < 25% of baseline), Respiratory depression,Sedation, Pruritis and Nausea/ Vomiting will be noted and treatedappropriately. Bradycardia will be treated with Injection Atropine 20mcg/kg IVand Hypotension by IV fluids/ injection Mephentermine 3 mg IV boluses.
Thedata will be collected in the study proforma and analyzed for statisticalsignificance with the statistician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I-II patients undergoing lower abdominal or lower limb surgery under spinal anesthesia.
排除标准
- •a)Patient refusal b)Allergy to Bupivacaine c)Body mass index (BMI) > 35 d)Intra-operative conversion to general anesthesia (GA) / inadequate or failed spinal block e)Pregnant and lactating mothers f)Known bleeding diathesis or with any coagulation abnormalities.
结局指标
主要结局
To compare the onset, peak and duration of sensory and motor block in fractionated and single bolus dose of spinal anesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries.
时间窗: 5,10,15,20,25,30,60,90,120,150,180,210 minutes after spinal injection
次要结局
- 1)To compare the intraoperative hemodynamics heart rate, saturation,systolic blood pressure, diastolic blood pressure, mean blood pressure and any side effects