Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- depth of sedation
研究概览
简要总结
This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.
详细描述
This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Both the patients and surgeon will be blinded from knowing the sedative agent
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian citizens of who is able to give valid consent
- •Patient planned for ERCP (either emergency or elective)
排除标准
- •Known hypersensitivity towards Ketamine or Midazolam
- •Patient refusal to participate or unable to give consent
- •Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
- •Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
- •Acute myocardial infarction, acute coronary syndrome (<3 months)
- •Tachyarrythmia
- •Pregnancy
- •IVDU or substance abuse patient
- •Patient with history of hallucination
- •Child's Pugh Class C
研究组 & 干预措施
Ketamine group
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
depth of sedation
时间窗: 1 hour
based on Ramsay Sedation Scale, from a scale of 1-6. 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response The aim of sedation is a score of 3-4
completion rate
时间窗: 1 hour
to evaluate completion rate between Ketamine and Midazolam group
次要结局
- Surgeon satisfaction score(within 4 hours after completion of ERCP)
- Patient satisfaction score(within 4 hours after completion of ERCP)
- evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms(24 hours)