Effect of Dexamethasone on Post-spinal Hypotension in Geriatric Patients Undergoing Orthopaedic Surgery At Tertiary Care Hospital Karachi.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Post spinal Anesthesia Hypotension
研究概览
简要总结
The goal of this clinical trial is to learn if intravenous dexamethasone is effective for prevention of post spinal hypotension in geriatric population undergoing orthopedic surgeries. The main question aim to answer is:
Does intravenous dexamethasone in participants undergoing orthopedic procedures of lower limb under spinal anesthesia prevents post spinal hypotension? Researchers are comparing two groups of participants
- Participants in (Dexamethasone Group) Group D are receiving intravenous dexamethasone 8mg preoperatively
- Participants in (Placebo Group) Group P are receiving placebo preoperatively.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing orthopedic surgery in spinal anesthesia. ASA ≤ 2.
排除标准
- •Patients with history of cardiac arrhythmias. Patients with history of acute coronary syndrome. Patient with history of polytrauma. Patients with contraindication to SA (e.g., coagulopathy, thrombocytopenia, allergy to local anesthetic agent) and those on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor) will be excluded.
研究组 & 干预措施
Placebo Group
Participants randomly allocated to this group will receive placebo preoperatively 20 minutes before spinal anesthesia
干预措施: Placebo (Other)
Dexamethasone Group
Participants randomly allocated to this group will receive intravenous dexamethasone 8mg preoperatively 20 minutes before spinal anesthesia
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Post spinal Anesthesia Hypotension
时间窗: From enrollment to 30 minutes after spinal anesthesia
Hypotension will be considered if there will be 25% decrease below the baseline for (Mean Arterial Pressure) MAP and will be managed by 300 ml of (Normal Saline) NS solution with incremental intravenous 5 mg doses of ephedrine. The proportion of patients with hypotension at any time during the first 20 min after induction of the (Spinal Anesthesia) SA and before starting the surgical procedure will be considered as the outcome of the study.
次要结局
未报告次要终点
研究者
Maria Shafi
Principal Investigator
Shaheed Mohtarma Benazir Bhutto Institue of Trauma