A Randomized Controlled Trial: Evaluating low dose Nebulized Dexamethasone in decreasing the incidence of Postoperative Sore Throat in Patients Undergoing General Anaesthesia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial aims to assess whether low dose nebulized dexamethasone can reduce the incidence and severity of postoperative sore throat POST in patients undergoing general anaesthesia with endotracheal intubation. POST is a frequent and unpleasant complication caused mainly by airway irritation from the endotracheal tube, high cuff pressure, prolonged intubation, and dryness of airway mucosa. Although self-limiting, POST affects patient comfort and satisfaction. Dexamethasone is known for its anti-inflammatory effects and is commonly used intravenously to reduce POST. Nebulized dexamethasone offers the advantage of direct airway delivery with fewer systemic effects.
The study will be a prospective, randomized, double blind, controlled trial conducted over 12 months in the operation theatre and postoperative recovery area of AIIMS Kalyani. Adult patients aged 18 to 65 years, classified as ASA 3 or 4 and scheduled for elective surgeries under general anaesthesia with an expected intubation duration of less than 3 hours, will be included. Patients with recent respiratory infection, chronic airway disease, steroid allergy, obesity, pregnancy, smoking history, head and neck surgery, or difficult airway conditions will be excluded.
A total of 72 patients will be enrolled based on sample size calculation. Participants will be randomly allocated into two groups. Group D will receive 4 mg dexamethasone in 4 mL saline via nebulization, while Group S will receive 5 mL normal saline. Nebulization will be performed 30 minutes before induction. A uniform anaesthesia protocol will be followed for all patients. Cuff pressure will be maintained at 20 to 22 cm H2O.
POST will be assessed at 0, 2, 8, 12, and 24 hours after exudation by blinded assessors using a 4-point severity scale. Secondary outcomes such as hoarseness and cough will also be recorded. Data will be analysed using appropriate statistical tests with significance set at P less than 0.05. Ethical approval and written informed consent will be obtained before study initiation.
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
- •Patients classified as ASA I or II.Patients scheduled for elective surgeries requiring general anesthesia and endotracheal intubation.Expected surgery duration of less than 3 hours.Anticipated single-attempt intubation with a Mallampati score of 3 and 4 without any active airway infection or chronic respiratory conditions.
排除标准
- •History of recent upper respiratory tract infection ,sore throat, chronic cough, or airway-related surgeries.Known hypersensitivity to corticosteroids or nebulization agents.Obesity with BMI more than 35 Pregnancy or lactation.
研究者
Kumari Sneha
AIIMS Kalyani
