PROSPECTIVE RANDOMIZED CONTROL DOUBLE BLINDED TRAIL ON PREOPERATIVE ORAL ZINC TABLET DECREASING INCIDENCE OF POSTOPERATIVE SORE THROAT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Primary aim of our study will be to assess the incidence of POST at 4 hours after surgery after zinc 40mg premedication
研究概览
简要总结
Post operative sore throat (POST) is a common complaint in patients recieving general anesthesia. Although symptoms often ameliorate without any treatment, prophylactic management improves patient satisfaction and impacts discharge from hospital.Zinc is a micronutrient with anti-inflammatory and antioxidant property which promotes growth, tissue repair and modulates immune system. As a topical agent zinc has been used for prevention of oral mucositis in patients receiving high dose chemotherapy. Oral zinc tablets has been shown to reduce the incidence and severity of POST. Zinc also prevents the cytokine release, decreases the reactive oxygen species, and subsequently decreases cyclooxygenase two expression, and prostaglandin E two release.
We hypothesized administration of oral zinc in form of dispersible tablet will reduce the incidence of POST due to its inherent anti-inflammatory and tissue healing properties. To test the hypothesis this study was designed to investigate the efficacy of oral zinc sulfate given 30 minutes preoperatively in reducing POST till 24 hours after surgery, where POST was caused by endotracheal intubation. The dispersible tablet form of zinc was preferred due to its easy availability in our country and comparatively better local effect on oropharyngeal mucosa.
The primary aim of our study will be to assess the incidence and severity of POST . The secondary aim will be to assess for any side effects such as nausea, vomiting, metallic taste, diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •American society of anesthesiologists grade 1 and 2 aged 18-60 years, posted for surgeries lasting greater than 1 hour and less than 6 hour duration under general anesthesia requiring tracheal intubation will be included for the study.
排除标准
- •Pregnant patients
- •Patients with recent history of sore throat
- •Malampatti grade greater than 2
- •Patients with zinc allergy
- •Traumatic or more than one attempt of intubation
- •Cormack-lehane score 3 and 4.
结局指标
主要结局
Primary aim of our study will be to assess the incidence of POST at 4 hours after surgery after zinc 40mg premedication
时间窗: Primary aim of our study will be to assess the incidence of POST at 4 hours after surgery after zinc 40mg premedication
次要结局
未报告次要终点
研究者
DR JALAJA K R
MANIPAL HOSPITALS, OLD AIRPORT ROAD,BANGLORE
