Dexamethasone Intravenous Versus Intrathecal in Prolonging the Duration of Spinal Anesthesia and Postoperative Analgesia in Elective Cesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Duration of sensory block in spinal anesthesia
研究概览
简要总结
The purpose of this study is to compare the the effect of intravenous and the intrathecal dexamethasone when added to spinal anesthesia in cesarean section.
详细描述
- Pre-operative settings:
Detailed preoperative examination and preoperative investigations (complete blood picture, Bleeding Time, prothrombin time and partial thromboplastin time) were performed. Age and weight were recorded. The patient was fasting for 8 hours preoperatively.
In the preanesthetic room, 18-gauge intravenous cannula was sited. Patients was preloaded with 5 mL/kg of lactated Ringer's solution over 20 minutes. The visual analogue scale (VAS) for pain was explained to the patients 2. Intra-operative Settings Inside the operating room, mean arterial blood pressure (MAP), heart rate (HR), electrocardiography (ECG) and peripheral oxygen saturation (SpO2) were obtained using standard non-invasive monitors and base line values were recorded.
The spinal technique was performed under complete aseptic condition with the patient in sitting position at the L3- L4 or L4 -L5 intervertebral space with 25-gauge spinal needle through midline approach. The spinal drugs were administered over 30 second according to each group.
Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients in childbearing period with an age of 18 years up to 40 years old scheduled to undergo elective cesarean section under spinal anesthesia.
- •All patients were of ASA II physical status with uncomplicated pregnancy and no comorbidity.
排除标准
- •Refusal of procedure or participation in the study by patients. Emergency cesarean section. Any contraindication to spinal anesthesia as infection at site of injection or history or evidence of coagulopathy.
- •Congenital anomaly of the spine. Psychiatric illness affecting the ability to properly communicate with the patient or to use the VAS for pain.
- •Receiving analgesics or corticosteroid drugs. Allergies to drugs used.
研究组 & 干预措施
IT group
Participants were received normal saline 2 mL intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 0.5 mL (2mg) dexamethasone diluted in 0.5 ml of 0.9% saline, overall 3 ml volume intrathecally. The dose of 2mg of dexamethasone was demonstrated by Amer (2018) to be the least effective intrathecal dose.
干预措施: Dexamethasone (Drug)
IV group
Participants were received dexamethasone 2 mL (8mg) intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Duration of sensory block in spinal anesthesia
时间窗: 4 months after starting the study
The primary objective of this study is to compare the efficacy of intrathecal dexamethasone with dexamethasone when used intravenously as an adjuvant to prolong the sensory block obtained by spinal anaesthesia and postoperative analgesia in cesarean section
次要结局
未报告次要终点
研究者
Marwa Emam
Lecturer
Ain Shams University