Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- sore throat
研究概览
简要总结
ABSTRACT:
The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.
99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.
For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years<age>15 years
- •no acute upper respiratory infections and no sore throat
- •candidate for elective surgery unrelated to the throat
- •The lack of airways difficulties
- •candidate for general anesthesia with intubation
- •no contraindications for receiving steroid
- •surgery time < 240 minutes
- •intubation up to 2 times
- •tracheal tube cuff pressure = 25-30 cm H2o
- •fasting for 8-6 hours prior to surgery
- •ASA I and ASAII and
- •Surgery under general anesthesia and endotracheal intubation
排除标准
- •use of nasogastric tube or throat packs
- •patients with upper respiratory tract infection
- •patients on steroid therapy were excluded from the study
研究组 & 干预措施
betamethasone gel
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
干预措施: betamethasone gel (Drug)
betamethasone gel
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
干预措施: distilled water (Drug)
lidocaine jelly
lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
干预措施: lidocaine jelly (Drug)
lidocaine jelly
lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
干预措施: distilled water (Drug)
结局指标
主要结局
sore throat
时间窗: 6 hours after surgery
For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).
cough
时间窗: 24 hours after surgery
For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).
hoarseness of voice
时间窗: 24 hours after surgery
For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).
次要结局
未报告次要终点
研究者
Fatemeh Shahbazi
Principal Investigator
Tehran University of Medical Sciences