Cholangitis, Choledochal Cyst, Choledocholithiasis, Pancreatic Cancer
Conditions
Keywords
Ketamine, Midazolam, sedation, ERCP
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.
Interventions
DRUGKetamine
Administration described in arm/ group description
DRUGMidazolam
Administration described in arm/ group description
DRUGPethidin
Administration described in arm/ group description
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received
Intervention model description
Patients will be randomized into the intervention or control group (Intervention group will receive Ketamine - Midazolam and control group will receive Midazolam- Pethidine as a sedative agent in ERCP
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Malaysia
Outcome results
None listed