Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia
To compare the depth of sedation
The depth of sedation is evaluated using ramsay sedation scale where the scale is 1 to 6, where higher score is better
Time frame: 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
To evaluate the efficacy of Ketamine- Midazolam as a sedative agent in ERCP in terms of sedation failure rate.
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.
Time frame: 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)
To detect if there are changes in MAP calculated from participants blood pressure readings
Time frame: 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
Measured using likert scale
Time frame: 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
Measured using likert scale
Time frame: Single point asessment at 2 hours after completion of procedure
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To compare the number of participants that developed an adverse event that led to abandonment of procedure
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.
Time frame: 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