Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from Baseline sore throat at 24 h
研究概览
简要总结
the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.
详细描述
Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained.
Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.
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
- Double (Participant, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who recieved general anesthesia with LMA
- •surgery duration < 2 hours
- •between 18-60 years of age
- •ASA1-2 scores
排除标准
- •Being younger than 18 years old or being over the age of 60
- •Patients with an ASA score of 3 and greater than 3
- •Active infections in the area to be acupuncture.
- •Prolonged bleeding time
- •Liver failure
- •Renal insufficiency
- •Heart failure 9 . Patients less than 30 kg
- •Uncontrolled hypertension
- •Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction
- •Those who do not have the ability to read and sign the consent form
- •Patients with gastroesophageal reflux
- •History of any herbal medicine use
- •Patients who do not want to sign the consent form
- •Patients with difficult LMA placement
- •17.Patients who cannot have LMA placement at one time
- •Intubated patients in whom LMA could not be placed
- •19 Patients whose operation time exceeds two hours
- •20 .Patients whose operation time is less than 30 minutes
结局指标
主要结局
Change from Baseline sore throat at 24 h
时间窗: baseline to 24 hours
postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.
Change from Baseline postoperative cough at 24 hours
时间窗: baseline to 24 hours
postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Change from Baseline postoperative snoring at 24 hours
时间窗: baseline to 24 hours
postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
次要结局
- duration of operation(24 hour)
- resistance to Laringeal mask placement (none, mild, moderate, severe)(24 hours)
- time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation(24 hours)