Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of ketofol in sedation
研究概览
简要总结
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.
详细描述
This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe acute cholangitis of either sex
- •Aged between 21-70 years
- •Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.
排除标准
- •Patients who had ASA physical status Grade VI,
- •Baseline SpO2 <90%,
- •Patients who had difficulty in communication,
- •Patients allergic to the studied medications,
- •Morbidly obese patients,
- •Patients with chronic obstructive pulmonary disease,
- •Complicated airway,
- •Pregnant patients.
研究组 & 干预措施
Ketofol group
Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Will receive Ketofol (ketamine: propofol concentration 1:4) prepared in 50 ml syringe containing dextrose 5% (each ml contained 8 mg propofol and 2 mg ketamine), administered as following; 5 ml of ketofol as loading then infusion titrated till targeted RSS score.
干预措施: Ketamine/Propofol (Drug)
Propofol group
Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.
干预措施: Propofol (Drug)
结局指标
主要结局
Efficacy of ketofol in sedation
时间窗: 24 hours
The time to reach Ramsay Sedation Scale score of 5 to ensure adequate sedation. This scale is between 1-6. The score 5 and 6 indicates adequate sedation while score \<5 indicates inadequate sedation.
次要结局
- Impact of ketofol on hemodynamics(24 hours)
- Impact of ketofol on oxygen saturation(24 hours)
研究者
Haidi Karam
Associate professor
Assiut University