EFFICACY AND SAFETY OF PERI-OPERATIVE INTRAVENOUS LIGNOCAINE IN PREVENTING THE POST OPERATIVE SORE THROAT – A PLACEBO CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- -Incidence of dysphagia and cough between lignocaine versus normal saline group
研究概览
简要总结
Sore throat after tracheal intubation has been one of the most common postoperative discomforts causing dissatisfaction among the patients. Incidence of post operative sore throat (POST) varies from 30% to 70%.1
Reason behind this is the irritation and inflammation of the airway caused by pressure exerted on the tracheal wall by the endotracheal tube (ETT) inserted during intubation,2 trauma/erosion during intubation and mucosal dehydration.3 Whilst medical staff may concentrate on avoiding problems during surgery, patients will only be aware of postoperative complications whether its minor or the major. Such complications might affect their satisfaction with treatment. Diameter and the pressure of cuff may also influence the prevalence and severity of postoperative sore throat.4
Many non-pharmacological such as laryngeal mask usage had been tried but when the ETT is the only choice in the patients, pharmacological measures to alleviate the incidence and severity of POST with variable success will be taken into consideration.4,5 Many research articles have been mentioned about the prophylactic use of lidocaine, dexamethasone and steroids or the combination of these drugs has been used for this purpose.6,7 Whereas the studies to analyse the efficacy of peri operative intravenous lignocaine are very less. Hence, we would like to conduct a prospective observational study in this regard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, aged between 18 to 65 years, posted for surgeries requiring GA.
- •Patients belonged to ASA 1 and 2 will be included -Patients willing to participate in the study by obtaining the written informed consent.
排除标准
- •Patients with abnormal coagulation profile or on anticoagulation therapy, severe anaemia, hypovolemia, shock, septicaemia and history of seizure disorder.
- •Allergy to the study drug.
- •Emergency surgeries -Smoker , prior history of sore throat -Patients who are on treatment with inhaled steroids for any condition.
结局指标
主要结局
-Incidence of dysphagia and cough between lignocaine versus normal saline group
时间窗: specific time at which the outcome will be assessed/estimated i.e.IMMEDIATELY, 6 HR , 12 HR AND 24 HR
-Analysing the incidence of Post operative sore throat between lignocaine versus normal saline group.
时间窗: specific time at which the outcome will be assessed/estimated i.e.IMMEDIATELY, 6 HR , 12 HR AND 24 HR
-Assessing the safety of peri operative intravenous lignocaine in preventing the incidence of sore throat.
时间窗: specific time at which the outcome will be assessed/estimated i.e.IMMEDIATELY, 6 HR , 12 HR AND 24 HR
次要结局
- Analysing the efficacy of peri operative intravenous lignocaine in preventing the incidence of sore throat(estimated immediately, 6hours , 12 hours and 24 hours)