Efficacy of Dexamethasone in Preventing Postspinal Hypotension in Elderly Patients Undergoing Orthopedic Surgery: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. However blocking of these fibers result in reduce signal transmission to blood vessels and heart resulting in fall in blood pressure. Various drugs can be used to treat or prevent this hypotension. One such drug is Dexamethasone which is a steroid. This drug can be administered before spinal anesthesia through Intravenous route to prevent fall in blood pressure.
详细描述
Lower limb orthopedic surgeries are carried out under Sub Arachnoid block which is associated with sympathectomy resulting in vasodilation and hypotension. The hypotension can compromise end organ perfusion and pre-disposes the person to end organ damage such as Myocardial infarction, stroke and renal injury. Therefore treatment and prevention of post spinal hypotension is one of the major goals to improve peri-operative outcomes. One such drug which can be used to prevent post spinal hypotension is Dexamethasone which can be given prophylactically to prevent post spinal hypotension as the drug causes increase in systemic vascular resistance thereby counteracting post spinal vasodilation and hypotension.
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)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing orthopedic surgery under spinal anaesthesia.
- •ASA I & II.
排除标准
- •Known case of ischemic heart disease.
- •Patients having contraindication to spinal anesthesia (e.g.- coagulopathy, thrombocytopenia, allergy to local anesthetic agent).
- •Patients using corticosteroids or drugs that affect serotonin (e.g., selective serotonin reuptake inhibitor).
- •Patients with uncorrected hypovolemia.
研究组 & 干预措施
Group Dexamethasone
Participants entering this arm of Parallel randomized control trial will receive 8mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia.
干预措施: Dexamethasone (Drug)
Group Placebo
Participants entering this arm of Parallel randomized control trial will receive 100ml Normal saline 1 hour before induction of spinal anesthesia.
干预措施: Placebo (Drug)
结局指标
主要结局
Systolic Blood Pressure
时间窗: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
This is the highest blood pressure during cardiac cycle occurring at the peak of systole measured by Non invasive automated blood pressure cuff
Diastolic Blood Pressure
时间窗: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
This is the lowest blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff
Mean Blood Pressure
时间窗: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
This is the average blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff
次要结局
- Number of Hypotensive episodes(Intraoperative period)
- Rescue Phenylephrine(Intraoperative period)
- Rescue intravenous fluid(Intraoperative period)
研究者
Muhammad Haroon Anwar
Principal Investigator
Pakistan Institute of Medical Sciences