Efficacy and Safety of Oral Magnesium vs. Oral Zinc in the Post-Operative Sore Throat (POST): A Prospective, Randomized, Double-blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Occurence of POST at 4 hours.
研究概览
简要总结
Postoperative sore throat (POST) is the second most common complication after general anesthesia which causes discomfort to the patient. Currently, there is no effective treatment which reduces the occurence and severity of post-sore throat after general anaesthesia. The current study is planned to assess the effect and safety of zinc and magnesium in reducing the occurence and severity of POST
After taking the informed consent, 2 hour prior to general anaesthesia participants will be asked to take 5 ml of water in which the study drug is dissolved as per group allocation. (Zn/Mg/or plain water). The rest of the procedure will be as per standard care of the operation. After operation, participant will be evaluated for post operative sore throat and adverse drug events at 0, 2, 4 and 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I and II.
排除标准
- •History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies 2) Chronic smokers 3) Patients with Mallampati airway grade of more than 2 4) Patients requiring more than one attempt for intubation or traumatic intubations 5) Patients requiring laryngeal mask Airway (LMA) placement 6) Patients allergic to zinc or magnesium 7) Patients undergoing head and neck surgeries 8) Pregnancy.
结局指标
主要结局
Occurence of POST at 4 hours.
时间窗: Occurence of POST at 4 hours.
次要结局
- Severity of POST at 0, 2 & 24 hours after the surgery.(Number of adverse effects in all three groups also recorded in secondary outcome.)
研究者
Dr Sumit Bansal
AIIMS, Rajkot