The Effectiveness of Preemptive Nebulized Dexamethasone in Reducing Post- Operative Sore Throat Following the Use of AMBU® AURAGAINTM Device: A Double Blind, Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of POST up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone
研究概览
简要总结
This study aims to study the effectiveness of preoperatively nebulized dexamethasone in reducing the incidence and severity of Post Operative Sore Throat, POST in patients undergoing surgery under general anesthesia using the Ambu® AuraGainTM SGA device, with secondary aims of determining the effectiveness of dexamethasone in reducing post-operative cough severity and hoarseness of voice
详细描述
The role of dexamethasone in reducing the incidence and severity of postoperative sore throat (POST) with ETT use is established in few studies. Some of the studies had done were found to have result on pertaining to efficacy of steroids in reducing incidences of POST in usage of SGA device, hence we decided to undertake this double-blinded, randomized study in patients undergoing general anaesthesia using the Ambu® AuraGainTM SGA device.
Dexamethasone which is 26.6 and 6.6 more potent than cortisol and prednisolone, acts via anti-inflammatory effects; inhibiting and reducing the release of inflammatory mediators. Hence this study aims to study the effectiveness of preoperative nebulized dexamethasone in reducing the incidence and severity of POST to improve patient satisfaction following general anaesthesia,and reduce morbidity.
OBJECTIVES
General:
To determine the effectiveness of preoperatively nebulized dexamethasone in reducing the incidence of post-operative sore throat following Ambu® AuraGainTM SGA device use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-70 years
- •American Society of Anaesthesiology (ASA) physical status of 1 and 2
- •Patients undergoing elective procedures under general anaesthesia between the data collection period suitable for SGA device
排除标准
- •Pre-existing sore throat/hoarseness on pre-operative assessment
- •Patients with history of postoperative nausea or vomiting
- •Recent (2 weeks) upper or lower respiratory tract infection
- •Known hypersensitivity to dexamethasone or on regular steroids
- •Uncontrolled diabetes of capillary blood sugar more than 10mmol/l on pre-operative assessment
- •Morbidly obese with BMI > 40 kg/m2
- •Procedure exceeding 3 hours duration
- •Procedure requiring prone or Trendelenburg position or manipulation of head post-induction
- •Oral and neck surgeries
- •Pregnant patients
- •Patients with cognitive disabilities
- •Patients requiring nasogastric tube or nasal temperature probe insertion
- •Patient refusal
研究组 & 干预措施
Dexamethasone
Receiving pre-operatively single dose nebulised dexamethasone 8mg prior to induction of general anaesthesia
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of POST up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone
时间窗: up to 24 hours post-operatively
Patients will be evaluated using scoring system for sore throat, cough and hoarseness
次要结局
- Incidence of hoarseness of voice up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone(up to 24 hours post-operatively)
- Incidence of cough up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone(up to 24 hours post-operatively)
研究者
Rhendra Hardy Mohamad Zaini
Associate Professor
Universiti Sains Malaysia