Combination Use of Intravenous Ketamine-midazolam As a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; a Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the depth of sedation
研究概览
简要总结
Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?
详细描述
Ketamine- Midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ERCP compared to Midazolam- Pethidine. The usage of sedative agent in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to:
- 20-45% failure of sedation during ERCP
- Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8%
Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used.
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)
盲法说明
Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years old which able to give valid consent
- •Patient planned for ERCP (either emergency or elective)
- •American Society of Anaesthesiologist (ASA) score of I-III
排除标准
- •Known hypersensitivity towards Ketamine or Midazolam
- •Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
- •Severe hypertension (BP>170/110) and tachycardia (Heart rate >110)
- •Acute myocardial infarction, acute coronary syndrome (< 6 months)
- •Tachyarrhythmia
- •Pregnancy
- •Intravenous drug user (IVDU) or substance abuse patient
- •History of hallucination
- •Child's Pugh class C
研究组 & 干预措施
Ketamine - Midazolam arm
Initial IV Ketamine of 0.5mg/kg with IV Midazolam 0.02mg/kg given over 1 minute. If depth of sedation not adequate, to give another bolus of IV ketamine 0.25mg/kg after 2 minutes with IV Midazolam 0.01mg/kg. If depth of sedation not adequate, to give another bolus of IV Ketamine 0.25mg/kg after 2 minutes and IV Midazolam 0.01mg/kg. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team
干预措施: Ketamine (Drug)
Ketamine - Midazolam arm
Initial IV Ketamine of 0.5mg/kg with IV Midazolam 0.02mg/kg given over 1 minute. If depth of sedation not adequate, to give another bolus of IV ketamine 0.25mg/kg after 2 minutes with IV Midazolam 0.01mg/kg. If depth of sedation not adequate, to give another bolus of IV Ketamine 0.25mg/kg after 2 minutes and IV Midazolam 0.01mg/kg. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team
干预措施: Midazolam (Drug)
Midazolam - Pethidine arm
Initial IV Midazolam 0.05mg/kg given over 1 minute with IV Pethidine 0.7mcg/kg. If depth of sedation not If adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes and IV Pethidine 0.7mcg/kg. If depth of sedation not adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team.
干预措施: Midazolam (Drug)
Midazolam - Pethidine arm
Initial IV Midazolam 0.05mg/kg given over 1 minute with IV Pethidine 0.7mcg/kg. If depth of sedation not If adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes and IV Pethidine 0.7mcg/kg. If depth of sedation not adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team.
干预措施: Pethidin (Drug)
结局指标
主要结局
To compare the depth of sedation
时间窗: Evaluated at specific timepoints during the procedure whch are: introduction of scope, canulation of bile duct, trawling of stones, removal of stent and removal of scope
The depth of sedation is evaluated using ramsay sedation scale where the scale is 1 to 6, where higher score is better
次要结局
- To evaluate the efficacy of Ketamine- Midazolam as a sedative agent in ERCP in terms of sedation failure rate.(Evaluated at specific timepoints during the procedure whch are: introduction of scope, canulation of bile duct, during sphincerotomy, removal of stent and removal of scope)
- To compare pre and post procedure mean arterial pressure (MAP)(Measured at specific time-pointswhich are: pre-sedation, 2 minutes after initiation of sedation and 5 minutes after the procedure is completed)
- To compare surgeon satisfaction in terms of sedation quality between both arms using a likert scale of 1 to 5 where a higher score is better(Single point asessment at the end of the procedure)
- To compare participant satisfaction in terms of procedure experience between both groups using likert scale of 1 to 10 where the higher score is better(Single point asessment at 2 hours after completion of procedure)
- To compare the number of participants that developed an adverse event that led to abandonment of procedure(Evaluated at specific timepoints during the procedure which are: introduction of scope, canulation of bile duct, during sphincerotomy, trawling of stones, removal of stent and removal of scope)
研究者
Prof Madya Dr. Azlanudin Azman
Associate Professor
National University of Malaysia