Effect of nebulized dexmedetomidine and saline nebulization for preventing post operative sore throat following general endotracheal anaesthesia for surgery in prone position: a double blinded placebo control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severity of post operative sore throat
研究概览
简要总结
Postoperative sore throat (POST) is a common complication following general anaesthesia.It causes patient discomfort & dis-satisfaction, potentially delaying their return to regular activities . Changing of position from supine to prone can change ETT cuff pressure & ET tube displacement which may affect the incidence of POST. ET tube displacement occurred in 91.7% of patients after supine-to-prone position change; of these, 48% of patients’ ET tube moved more than 10 mm
and ET tube cuff pressure changed in 86.3 percent 0f patients. No study has been conducted to evaluate the effectiveness of dexmedetomidine nebulization in decreasing POST in prone position surgeries. We plan this study to investigate the prophylactic effect of dexmedetomidine nebulization in decreasing POST in patients undergoing surgeries under general anaesthesia with tracheal intubation in prone position.
Dexmedetomidine is a potent alpha-2 receptor agonist. It cause sedation, pain alleviation, & diminished sympathetic activity .Local application of nebulized dexmedetomidine yields analgesic and anti-inflammatory effects by lowering postoperative serum levels of IL-6, IL-8, & TNF-α.Dexmedetomidine through nebulization is well tolerated and represents a promising new administration approach that has minimal effects on the cardiovascular and the respiratory systems
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Adult patients aged 18-65 years scheduled for elective surgery requiring prone position for surgery under general anaesthesia with endotracheal intubation
- •ASA (American Society of Anaesthesiologists) physical status I.
- •II patients
- •Expected surgical time: Atleast two hours.
排除标准
- •Patients with preoperative sore throat or upper respiratory tract infection
- •Heart rate less than 60per minute SBP less than 90mm Hg
- •Pregnant patients
- •Requiring more than two attempts for the insertion of an endotracheal tube
- •Use of throat pack
- •Surgery lasting more than three hours or expected postoperative mechanical ventilation
- •Use of video laryngoscope for endotracheal intubation.
结局指标
主要结局
Severity of post operative sore throat
时间窗: At 6th hour post operatively
次要结局
- Post operative sore throat(0,2,6,12,24 hrs)
- Significant post operative sore throat(0,2,6,12,24 hrs)
- Post operative sore throat and hoarseness of voice(0,2,6,12,24hrs)
研究者
Dr Shameem P Shooja
Junior resident department of anaesthesia pain medicine and critical care AIIMS NEW DELHI