Ketamine-midazolam As a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.
- Conditions
- CholedocholithiasisCholedochal CystCholangitisPancreatic Cancer
- Interventions
- Registration Number
- NCT06111872
- Lead Sponsor
- National University of Malaysia
- Brief Summary
Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?
- Detailed Description
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:
1. 20-45% failure of sedation during ERCP
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine - Midazolam arm Ketamine 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 Ketamine - Midazolam arm Midazolam 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 Midazolam - Pethidine arm Midazolam 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. Midazolam - Pethidine arm Pethidin 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.
- Primary Outcome Measures
Name Time Method To compare the depth of sedation 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
- Secondary Outcome Measures
Name Time Method 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 Sedation failure rate is defined as inability of the sedation used to adequately sedate a patient for initiation and completion using ramsay sedation scale where the scale is 1-6, where higher score is better.
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 detect if there are changes in MAP calculated from participants blood pressure readings
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 Measured using likert scale
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 Measured using likert scale
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 Adverse event by monitoring patient vital signs including blood pressure, pulse rate, oxygen saturation and procedure will be abandoned if the parameters reach a pre-set cut-off point.
Systolic blood pressure \<90mmHg or \>180mmHg, Pulse rate of \<60/min or \>150/min and oxygen saturation \<95% despite supplemental oxygen therapy via nasal canula.
Trial Locations
- Locations (1)
Hospital Canselor Tuanku Muhriz UKM
🇲🇾Cheras, Kuala Lumpur, Malaysia