Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patients : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of cough reflex during extubation
研究概览
简要总结
Study Hypothesis: The combination of dexmedetomidine and lidocaine administered as laryngopharyngeal topical spray provides superior suppression of extubation cough reflex compared to lidocaine alone or placebo, without compromising recovery or increasing adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective thyroidectomy under general anesthesia with endotracheal intubation
- •Provided written informed consent
排除标准
- •Known allergy or contraindication to dexmedetomidine, lidocaine, or study medications
- •Pre-existing cough or respiratory tract infection within 2 weeks
- •History of chronic cough or reactive airway disease (asthma, COPD)
- •Significant cardiovascular disease (arrhythmias, uncontrolled hypertension, heart failure)
- •Hepatic or renal dysfunction (liver enzymes >2× upper normal limit, creatinine >1.5 mg/dL)
- •Pregnancy or breastfeeding
- •Anticipated difficult airway (Mallampati class III-IV, limited neck extension)
- •Preoperative use of antitussive medications or opioids
- •Body mass index >35 kg/m²
- •Emergency surgery
- •Participation in another interventional trial within 30 days
研究组 & 干预措施
Dex-Lido Group (n=40)
Received topical spray containing dexmedetomidine 1 μg/kg combined with 2% lidocaine (total volume 5 mL)
干预措施: · Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume (Drug)
Lido Group (n=40)
Received topical spray containing 2% lidocaine alone (5 mL)
干预措施: · Lido solution: 2% lidocaine, 5 mL (Drug)
Control Group (n=40)
Received topical spray containing 0.9% normal saline (5 mL)
干预措施: · Control solution: 0.9% normal saline, 5 mL (Drug)
结局指标
主要结局
Incidence of cough reflex during extubation
时间窗: 2 minutes following complete tube extubation
any visible or audible cough occurring from the time of endotracheal tube cuff deflation until 2 minutes following complete tube removal.
次要结局
- Cough Severity(10 minutes post extubations)
- Postoperative Sore Throat(at 1, 6, 24, and 48 hours postoperatively)
研究者
Islam Mokhtar Ahmed
Assistant professor
Sohag University