Effect of Intravenous Dexamethasone on the Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- regression of sensory block
研究概览
简要总结
The use of dexamethasone, administered either systemically or perineurally, as an adjunct to peripheral or neuraxial regional blocks, is currently one of the hottest topics in the field of regional anesthesia.
详细描述
A large number of clinical studies have investigated this off-label application of dexamethasone in recent years, with many reporting enhanced sensory block and/or improved postoperative analgesia following either intravenous (i.v.) or perineural dexamethasone. Dexamethasone is potent, selective glucocorticoid having minimal mineralocorticoid action. Systemic anti-inflammatory and immunosuppressive properties may be responsible for the prolongation of analgesia when administered intravenously. Various studies proved the efficacy of steroids for the prolongation of the effects of regional nerve blocks. We decided to conduct the present study to evaluate the effects of intravenous (IV) dexamethasone on the subarachnoid block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes 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 with American Society of Anesthesiologists score I-III,
- •Patients undergoing lower abdominal surgery under hyperbaric bupivacaine spinal anesthesia
排除标准
- •History of allergy to amide LAs or dexamethasone,
- •Presence of a preexisting lower limb neurological deficit
- •Chronic use of corticosteroids.
研究组 & 干预措施
normal saline group (NS)
patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes after spinal anesthesia
干预措施: Placebo (Drug)
dexamethasone group (SD)
patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline in 5-10 minutes after spinal anesthesia
干预措施: i.v dexmethasone (Drug)
结局指标
主要结局
regression of sensory block
时间窗: 5, 10, 20, and 30 minutes after injection of local anesthetic(LA)
Onset to regression of 2 dermatomes evaluated using a Von Frey6.1-g filament (Bioseb; North Coast Medical, Gilroy, CA)
次要结局
未报告次要终点
研究者
Amani Hassan Abdel-Wahab
assistant professor
Assiut University