Comparative evaluation of efficacy of add on chlorhexidine with lignocaine gargles for prevention of post operative sore throat after ambu auragain laryngeal mask airway insertion
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To compare the Incidence and severity ( subjective grading score ) of sore throat in Group C (lignocaine +chlorhexidine) and Group
研究概览
简要总结
Post operative sore throat is one of the most common post-operative
complication with an incidence of 65%. Many pharmacological and non
pharmacologicaltherapeutic measures have been tested to prevent POST with variable
results. We used AmbuAuragaineLMA in this study as it is easy to insert,less invasive and is
associated with minimal haemodynamic response and fewer complications compared to ETT.
A total of 160 adult patients (18-65 years age) ASA I,II and III
undergoing surgery in general anaesthesia with Ambu Auragain LMA will be enrolled in this
prospective randomized study.Patients will be allocated into two groups Group C (viscous
lignocaine+chlorhexidine) and Group L (viscous lignocaine+normal saline) of 80 patients each.list.Group C will receive 15ml of 2% xylocaine
viscous with 5 ml chlorhexidine and group L will receive 15ml of 2% xylocaine viscous with 5
ml normal saline as gargle solution 15 minutes before the induction of anaesthesia for 30
seconds. In the operation theatre after standard anaesthesia induction Ambu Auragain LMA
will be inserted. Incidence of post-operative sore throat will be evaluated using a 4- point scale
at 0h,1h,2h,4h,12h and 24h in post anaesthesia care unit (PACU).
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patients of age 18-65 years of either sex posted for elective procedure not more than 3 hours duration under general anaesthesia with AmbuAuragain LMA.
- •2 American Society Of Anaesthesiologists (ASA) status I, II and III.
排除标准
- •1 Smokers 2 Any known contraindication or hypersensitivity to study drugs.
- •3 Preoperative sore throat 4 Upper or lower respiratory tract infection 5 Anticipated difficult intubation 6 Risk of aspiration(full stomach, history of gastroesophageal reflex disease, hiatus hernia) 7 Morbid obesity ; BMI > 35 kg/m2 8 Derranged coagulation.
结局指标
主要结局
To compare the Incidence and severity ( subjective grading score ) of sore throat in Group C (lignocaine +chlorhexidine) and Group
时间窗: In the postanaesthesia care unit (PACU), all patients will be evaluated for post operative sore throat at 0,1, 2, 4, 12 and 24 hrs
L (lignocaine + Normal saline).
时间窗: In the postanaesthesia care unit (PACU), all patients will be evaluated for post operative sore throat at 0,1, 2, 4, 12 and 24 hrs
次要结局
- Post operative side effects if any like nausea/vomiting , sedation,bleeding from oral cavity will be noted.(24 hours)
研究者
Dr Kamakshi Garg
Dayanand Medical College and Hospital