Status:
COMPLETED
Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.
Lead Sponsor:
National University of Malaysia
Conditions:
Cholangitis
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06111872
Start Date
July 18 2023
End Date
October 25 2024
Last Update
March 25 2025
Active Locations (1)
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1
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia, 56000