A comparative study of nebulised ropivacaine and dexmedetomidine in the prevention of postoperative sore throat following general anaesthesia : A prospective study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of nebulised Ropivacaine and nebulised Dexmedetomidine in preventing postoperative sore throat following intubation in patients undergoing general anaesthesia.
研究概览
简要总结
This is a prospective study comparing the efficacy of nebulized Ropivacaine and nebulized Dexmedetomidine in preventing postoperative sore throat following intubation in patients undergoing general surgery, it compares the efficacy of nebulized Ropivacaine and nebulized Dexmedetomidine on the haemodynamic response before and after intubation and also compares the incidence of side effects of nebulized Ropivacaine and nebulized Dexmedetomidine postoperatively in patients.
Patients fulfilling the inclusion criteria will be randomly divided into two groups of 30 each. Group D will be nebulized with Dexmedetomidine 50 mcq (0.5 mL) along with 4.5 mL of saline, totalling 5 mL and Group R will be nebulized with Ropivacaine 0.75% 5 mL. Nebulization will be given in the preoperative room 30 minutes before induction as per the group allocation.
Postoperative sore throat will be assessed at 1,2,4,6,12, and 24 hrs after surgery. Haemodynamic data like pulse rate, heart rate and blood pressure will be assessed before nebulization, after nebulization, before tracheal intubation, after tracheal intubation, 5 minutes after tracheal intubation, at the closure of skin incision, immediately after tracheal extubation, and 5 minutes after tracheal extubation.
All adverse events occurring during the postoperative period related to the use of nebulized Ropivacaine and nebulized Dexmedetomidine will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Patients willing to give consent American Society of Anaesthesiology physical status I and II Age between 18 to 60 years Airway assessment by Mallampati grade I and II Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation.
排除标准
- •Duration of surgery is more than 3 hrs Cardiopulmonary comorbidities Patients receiving corticosteroids Pre-existing pharyngeal laryngeal disease and sore throat.
结局指标
主要结局
To compare the efficacy of nebulised Ropivacaine and nebulised Dexmedetomidine in preventing postoperative sore throat following intubation in patients undergoing general anaesthesia.
时间窗: Postoperative sore throat will be assessed at 1,2,4,6,12 and 24 hours after surgery. | Haemodynamic data will be assessed before nebulisation, after nebulisation, before tracheal intubation, after intubation, 5 minutes after intubation, at closure of skin incision, immediately after extubation, 5 minutes after extubation. | All adverse events occurring during the postoperative period related to the use of nebulised ropivacaine and dexmedetomidine will be assessed for the next 24 hours.
To compare the efficacy of nebulised ropivacaine and nebulised dexmedetomidine on the haemodynamic response before and after intubation.
时间窗: Postoperative sore throat will be assessed at 1,2,4,6,12 and 24 hours after surgery. | Haemodynamic data will be assessed before nebulisation, after nebulisation, before tracheal intubation, after intubation, 5 minutes after intubation, at closure of skin incision, immediately after extubation, 5 minutes after extubation. | All adverse events occurring during the postoperative period related to the use of nebulised ropivacaine and dexmedetomidine will be assessed for the next 24 hours.
To compare incidence of side effects of nebulised ropivacaine and nebulised dexmedetomidine postoperatively in patients undergoing general anaesthesia.
时间窗: Postoperative sore throat will be assessed at 1,2,4,6,12 and 24 hours after surgery. | Haemodynamic data will be assessed before nebulisation, after nebulisation, before tracheal intubation, after intubation, 5 minutes after intubation, at closure of skin incision, immediately after extubation, 5 minutes after extubation. | All adverse events occurring during the postoperative period related to the use of nebulised ropivacaine and dexmedetomidine will be assessed for the next 24 hours.
次要结局
未报告次要终点
研究者
Bhavani I Kolhar
Sapthagiri Institute of Medical Sciences and Research Centre