Status:
RECRUITING
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Lead Sponsor:
Universiti Kebangsaan Malaysia Medical Centre
Conditions:
Ketamine Adverse Reaction
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
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 Pethid...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Malaysian citizens of who is able to give valid consent
- Patient planned for ERCP (either emergency or elective)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04490031
Start Date
March 1 2020
End Date
April 30 2021
Last Update
July 28 2020
Active Locations (1)
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1
University Kebangsaan Malaysia Medical center
Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000