Comparing the Effect of Different Ratio of Propofol-Ketamine Mixture (Ketofol) (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Level of Propofol Usage
研究概览
简要总结
Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
详细描述
Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having ERCP procedures using sedatives
- •ASA (American Society of Anesthesiologist) physical status Class I to III
- •Body mass index (BMI) of 18-30 kg/m2
- •Willing to participate in the study
排除标准
- •Patients with a history of allergic reaction to medications used in the study
- •Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
- •Patients with unstable hemodynamic
- •Patients with psychiatric medications
- •Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women
研究组 & 干预措施
K61
Patients in K61 group received propofol and ketamine in a ratio of 6:1. The 6:1 ketofol mixture was made by mixing 30 mL of 1% propofol (10 mg/mL) and 1 mL of ketamine (50 mg/ml), then 19 mL of 0.9% NaCl was added until the volume of the mixture was 50 mL. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun).
干预措施: Propofol and Ketamine Mixture (Ketofol) (Drug)
K41
Patients in K41 group received propofol and ketamine in a ratio of 4:1. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun).
干预措施: Propofol and Ketamine Mixture (Ketofol) (Drug)
结局指标
主要结局
Level of Propofol Usage
时间窗: 1 hour
Level of propofol needed during the procedure
次要结局
- Recovery Time(15 minutes)
研究者
Adhrie Sugiarto
Principal Investigator
Indonesia University