Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- the incidence of sore throat 1 hour after extubation.
研究概览
简要总结
Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.
详细描述
The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia.It is an undesirable events experienced by patients after general anaesthesia. Various pharmacological agents have been applied to reduce POST, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. However, these agents may have some systemic and local side effects. Therefore, various non-pharmacological applications have been investigated to reduce sore throat. Cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. Although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. Therefore, we hypothesized that colding of endotracheal tube may decrease POST associated with airway inflammation. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. This study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who were entubated with an ETT. Those who accept the research Elective surgery Patients in American Society of Anaesthesiologists (ASA) I and II class 18 years and over Mallampati classification I and II Operation time more than 1 hour
排除标准
- •Patients with sore throat and lower respiratory tract infection Patients with a history of allergies
结局指标
主要结局
the incidence of sore throat 1 hour after extubation.
时间窗: 1 hour after extubation
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
次要结局
- the severity of sore throat 1 hour after extubation.(1 hour after extubation)
- the incidence of sore throat 4 hour after extubation.(4 hour after extubation)
- the incidence of postoperative respiratory infection(7 days after operation)
- the incidence of sore throat 24 hour after extubation.(24 hour after extubation)
- the incidence of dysphonia(24 hour after extubation)
- the severity of sore throat 4 hour after extubation.(4 hour after extubation)
- the severity of sore throat 12 hour after extubation.(12 hour after extubation)
- the severity of sore throat 24 hour after extubation.(24 hour after extubation)
- the incidence of sore throat 12 hour after extubation.(12 hour after extubation)
- the incidence of dysphagia(24 hour after extubation)
研究者
Sibel Catalca
Principal Investigator
Baskent University