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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
140
patient in Ketamine group will be given Ketamine as sedative agent
University Kebangsaan Malaysia Medical center
Bandar Tun Razak, Kuala Lumpur, Malaysia
RECRUITINGdepth of sedation
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
Time frame: 1 hour
completion rate
to evaluate completion rate between Ketamine and Midazolam group
Time frame: 1 hour
Surgeon satisfaction score
subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent
Time frame: within 4 hours after completion of ERCP
Patient satisfaction score
subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent
Time frame: within 4 hours after completion of ERCP
evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms
recording the adverse events of each sedation. 1. Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg 2. Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg 3. Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute 4. Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute 5. Hypoxia: defined by oxygen saturation less than 95% 6. Respiratory rate abnormality 7. Nausea, vomiting, emergence symptoms
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Time frame: 24 hours