Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- the incidence and severity of POST
研究概览
简要总结
Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with tracheal intubation than in GA with the supraglottic airway Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-60 years.
- •Of both sex.
- •American Society of Anesthesiologists Physical Status (ASA PS) I-II.
- •Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.
排除标准
- •a- History of chronic obstructive History of sore throat or upper respiratory tract infection.
- •b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati grade more than II. e- Known allergic to study drug. f- More than one attempt is required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l- Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or steroids).
研究组 & 干预措施
(K) Ketamine group
40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization
干预措施: Ketamine (Drug)
(S) Saline group
40 patients will receive saline nebulization (5ml).
干预措施: saline nebulization (Other)
结局指标
主要结局
the incidence and severity of POST
时间窗: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.
次要结局
- evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.(at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.)
研究者
Doaa Ahmed Abdellatif
Resident-anesthesia,ICU and pain manegment department-sohag hospital university
Sohag University