Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- The Incidence of Post-operative sore throat
研究概览
简要总结
Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation.
详细描述
Design: A prospective, randomized, controlled study. Setting: Single-center university hospital. Participants: The study included 168 patients undergoing thyroid surgery under general anesthesia with endotracheal intubation.
Interventions: The patients were allocated randomly into the following 3 groups: the control group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and another 5ml of normal saline was injected intravenously when the incision was washed and sutured；the pre-tramadol group: patients will be injected intravenously 5ml of tramadol (1mg / kg) 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. the post-tramadol group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and 5ml of tramadol (1mg / kg) was injected intravenously when the incision was washed and sutured. Postoperatively, all patients will receive standard treatment.
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)
盲法说明
The anesthesia provider will be blinded to the intervention group allocation. All patients will be blinded. The primary investigator will be blinded. The resident researcher who will be the outcome assessor will also be blinded. The care provider will be blinded.
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 with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.
排除标准
- •History of thyroid surgery A history of preoperative sore throat; Pregnancy; Retrosternal goiter; Thyroid tumor invading trachea need trachea reconstruction; Potentially difficult airway; Clinical diagnosis of chronic sore throat; Clinical diagnosis of psychosis; Tracheotomy after operation； Transfer to intensive care unit after operation； Contraindications to tramadol； Body mass index (BMI) > 30kg/m^2.
研究组 & 干预措施
Placebo group
5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.
干预措施: Normal Saline (Other)
pre-tramadol group
5ml of tramadol containing 1mg / kg was injected intravenously 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured.
干预措施: Tramadol hydrochloride (Drug)
post-tramadol group
5ml of normal saline was injected intravenously 15 minutes before anesthesia and 5ml of tramadol containing 1mg / kg was injected intravenously when the incision was washed and sutured.
干预措施: Tramadol hydrochloride (Drug)
结局指标
主要结局
The Incidence of Post-operative sore throat
时间窗: 24 hours following extubation of endotracheal tube
The incidence of postoperative sore throat at 24 hours after extubation.
次要结局
- The Incidence of Post-operative sore throat(4 hours following extubation of endotracheal tube)
- The severity of Post-Operative Sore Throat(30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube)
- The incidence of of postoperative hoarseness.(30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube)
- The severity of postoperative hoarseness(30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube)
研究者
zegeng su
Attending doctor/ Master of medicine
Affiliated Cancer Hospital of Shantou University Medical College