Effect of Intravenous Infusion of Magnesium Sulphate on Arterial Oxygenation and Pulmonary Mechanics in Patients With Chronic Obstructive Pulmonary Diseases Undergoing Cancer Larynx Surgery. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- lung oxygenation
研究概览
简要总结
Chronic Obstructive Pulmonary Disease [COPD] is a major cause of chronic morbidity and mortality worldwide. COPD is characterized by persistent progressive airflow limitation that adversely affects the ventilation/perfusion (V/Q) matching and mechanics of the respiratory muscles and leads to hypoventilation and reduced gas transfer. COPD was identified as a significant comorbidity associated with increased incidences of postoperative pulmonary complications and prolonged hospital stay. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. Administration of MgSO4 in patients with stable COPD was associated with reduced lung hyperinflation and improvement of respiratory muscle strength. This randomized control trial is designed to assess the effect of intravenous MgSO4 infusion on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications and length of hospital stay in patients with COPD undergoing cancer larynx surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cancer larynx surgery (partial laryngectomy, total laryngectomy with or without neck dissection).
- •Age more than 40 years old
- •ASA physical status II and III.
- •Diagnosed as having COPD by preoperative spirometry. The classification is bases on the post-bronchodilators forced expiratory volume in the first second (FEV1). Mild COPD is diagnosed when FEV1 is > 80% of predicted while moderate COPD is diagnosed when FEV1 is < 80% and > 50% of predicted and sever COPD is diagnosed when FEV1 is < 50% and > 30% of predicted
排除标准
- •o Patients with heart failure.
- •History with arrhythmias or treatment with antiarrhythmic drugs.
- •Patient with heart block or on beta blockers or calcium channel blockers.
- •Patients with impaired renal function (creatinine > 2)
- •Patients with impaired liver function (ALT more than 2 folds).
- •Patient with combined restrictive and obstructive pulmonary disease.
- •Patients with preoperative tracheostomy.
- •Patients with huge mass obstructing > 50% of the view. (due to its influence on the spirometry measurements).
研究组 & 干预措施
Mg-group
10% MgSO4 solution will be used, a loading dose of 30mg/kg over 20 min (equivalent to infusion rate of 0.9 ml/kg/hr for 20 min) will be given followed by continuous infusion of 10mg/kg/hr (equivalent to infusion rate of 0.1ml/kg/hr).
干预措施: Magnesium Sulphate (Drug)
结局指标
主要结局
lung oxygenation
时间窗: over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.
PaO2/FiO2 immediately after arrival to the PACU
次要结局
未报告次要终点
研究者
Abeer Ahmed, MD
Assistant Professor of Anesthesia and SICU - Faculty of Medicine - Cairo University
Cairo University