NCT04908592已完成4 期
Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).
研究概览
简要总结
- Geriatric patients who undergo general anesthesia experience post induction hypotension which is treated with intravenous fluids and ephedrine. The main cause of post-induction hypotension is the decrease in the sympathetic outflow causing arterial vasodilatation, a decrease in venous return and consequently the activation of the Bezold Jarish reflex (BJR) that elicits a triad of bradycardia, vasodilatation and further hypotension. BJR is elicited by activation of 5-HT3 receptors within the intracardiac vagal nerve endings.
- Glucocorticoids in general inhibit 5-HT3 expression and dexamethasone was found to decrease the level of 5-HT3 in the cerebral cortex and hippocampus in developing rats. So, the research team hypothesizes that dexamethasone can attenuate the postinduction hypotension in geriatric patients undergoing general anesthesia if administered 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
- •Elective surgery under general anesthesia.
排除标准
- •Emergency surgeries.
- •Ischemic heart disease.
- •Peptic ulcer & active infection.
- •Psychiatric disorder.
- •Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).
研究组 & 干预措施
D Group (50 patients)
Active Comparator
干预措施: Dexamethasone (Drug)
C Group (50 patients)
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).
时间窗: intraoperative
The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University
研究点 (1)
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