About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Malaysian citizens of who is able to give valid consent
Patient planned for ERCP (either emergency or elective)
Disqualifiers
Known hypersensitivity towards Ketamine or Midazolam
Patient refusal to participate or unable to give consent
Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
Trial design
Crossover
Treatments tested in this trial
Ketamine Hydrochloride
Drugpatient in Ketamine group will be given Ketamine as sedative agent
Treatment groups
Trial outcomes
Primary outcomes
depth 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
completion rate
to evaluate completion rate between Ketamine and Midazolam group
Secondary outcomes
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
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
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
Locations
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Sponsors and contacts
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