NCT01774292已完成4 期
Evaluation of the Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation in Surgeries Without Nitrous Oxide Lasting More Than 2 Hours
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Coughing
研究概览
简要总结
The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.
详细描述
The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours
排除标准
- •Patient refusal
- •Lidocaine allergy
- •Any allergies to drugs or anesthetics used during the study
- •Under 18 years of age
- •Previous airway surgery
- •Cormack 3 or 4 or anticipated difficult airway
- •Upper respiratory tract infection in the last month
- •Active respiratory disease
- •Chronic cough or throat pain
- •Gastro-esophageal reflux disease or at risk for aspiration
结局指标
主要结局
Coughing
时间窗: 24 hours after the end ofsurgery
次要结局
- Nausea and Vomiting(24 hours after end of surgery)
- Throat pain(24 hours after the end of surgery)
- Hoarseness of the voice(24 hours after end of surgery)
研究者
Yanick Sansoucy
Anesthesiologist
Université de Sherbrooke
研究点 (2)
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