Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Conditions
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Ketamine Adverse Reaction

Intervention / Treatment
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* Drug: Ketamine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malaysian citizens of who is able to give valid consent Patient planned for ERCP (either emergency or elective) Exclusion Criteria: 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) Acute myocardial infarction, acute coronary syndrome (<3 months) Tachyarrythmia Pregnancy IVDU or substance abuse patient Patient with history of hallucination Child's Pugh Class C

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Midazolam group<br>Standard sedation for ERCP in UKMMC | |
| Experimental: Ketamine group<br> | Drug: Ketamine Hydrochloride<br>* patient in Ketamine group will be given Ketamine as sedative agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth of sedation | based on Ramsay Sedation Scale, from a scale of 1-6. Patient is anxious and agitated or restless, or both Patient is co-operative, oriented, and tranquil Patient responds to commands only Patient exhibits brisk response to light glabellar tap or loud auditory stimulus Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus Patient exhibits no response The aim of sedation is a score of 3-4 | 1 hour | 
| completion rate | to evaluate completion rate between Ketamine and Midazolam group | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute Hypoxia: defined by oxygen saturation less than 95% Respiratory rate abnormality Nausea, vomiting, emergence symptoms | 24 hours |