Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cumulative Propofol Consumption
研究概览
简要总结
It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
详细描述
The study was approved by Ethics Committee of Indonesia University. It was a single-blind randomized clinical trial at Cipto Mangunkusumo Hospital - Jakarta during August to September 2018. 72 subjects were recruited and randomly assigned into 2 groups. Patients in group B were given 0.15% mouthwash with benzydamine hydrochloride prior to procedure while patients in group C were given mouthwash with 15 ml of water. Cumulative propofol consumption per minute per kg body weight, and incidence of postoperative sore throat were measured for each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing ERCP
- •ASA I-III
- •BMI 18-30 kg/m2
排除标准
- •allergic to propofol
- •contraindicated to propofol
- •had throat wound or laceration
- •received analgesics or steroid in 24 hours priorly
- •unstable during sedation
- •procedure longer than 90 minutes
研究组 & 干预措施
Benzydamine Hydrochloride Group
Subjects who were allocated in benzydamine group would gargle with 15 of ml benzydamine hydrochloride 0.15% before sedation started.
干预措施: Benzydamine Hydrochloride 0.15% Oral Rinse (Drug)
Control Group
Subjects who were allocated in control group would gargle with 15 ml of water before sedation started.
干预措施: Water (Drug)
结局指标
主要结局
Cumulative Propofol Consumption
时间窗: 90 minutes
About 1 mg/kg Propofol was initially administered to sedate the subjects. If the subject's RSS (Ramsay Sedation Scale) rose, 0.3 mg/kg was additionally given. The amount of propofol used, as in mg/kg, during the ERCP procedure was recorded.
Incidence of Sore Throat
时间窗: 4 hours
Sore throat incidence after ERCP procedure was recorded
次要结局
未报告次要终点
研究者
Adhrie Sugiarto
Medical Staff
Indonesia University