Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Prevention of postdural puncture headache
研究概览
简要总结
This study will be conducted at Ain Shams University Hospital in Operating Theatre after ethical committe approval number (MS 32/ 2020). It is a prospective randomized controlled study will be done on patients undergoing lower abdominal and lower limb surgeries under spinal anethesia,Eligible patients will be randomized by computer system to one of two groups, either intravenous dexamethazzoe 8 mg with intrathecal heavy bupivacaine 0.5% or intrathecal 4mg dexamethazone with intrathecal heavy bupivacaine 0.5%. .
详细描述
Patients will be randomly divided into two equal groups: Group 1: patients receive intrathecal 3 ml bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline. Group 2: patients receive intrathecal 3 ml bupivacaine 0. 5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline. Upon patients' arrival into the operating room, peripheral oxygen saturation (SPO2), ECG, pulse rate (PR), and systolic and diastolic blood pressures will be monitored one of the researchers and recorded every 5 minutes till the end of surgery. In a sitting position and with antiseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not not aware of the type of medications injected. Subsequently, the patients were put in the supine position, and given oxygen 3 L/minutes by nasal prongs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double (participant and outcome assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ASA I or II undergoing lower limb surgeries under spinal anesthesia
- •Patients ASAI or II undergoing lower abdominal surgeries under spinal anesthesia.
排除标准
- •Emergency surgeries.
- •Patients with uncompensated heart diseases.
- •Patients with coagulopathy.
- •Presence of infection at site of injection of spinal anesthesia.
研究组 & 干预措施
intravenous dexamethazone group
Patients receive intrathecal 3 ml heavy bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline,to prevent postdural puncture headache. Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not aware of the type of medications injected.
干预措施: Dexamethasone intravenous (Drug)
intrathecal dexamethazone group
Patients receive intrathecal 3 ml heavy bupivacaine 0.5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline to prevent postdural puncture headache. Spinal anesthesia will be done in a sitting position under complete aseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not aware of the type of medications injected.
干预措施: Dexamethasone intrathecal (Drug)
结局指标
主要结局
Prevention of postdural puncture headache
时间窗: 48 hours after spinal anesthesia
prevention of postdural puncture headache after spinal anesthesia in the first 48 hours postoperatively
次要结局
- Duration of sensory block(4 hours from injection of drug in subarachnoid space.)
研究者
Ashraf Elsayed Elagamy
Assisstant professor Anesthesia,Intensive care and pain management
Ain Shams University