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Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

Recruiting
18 years and older
All
Phase 2

Overview

Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?

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 in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to:

  1. 20-45% failure of sedation during ERCP
  2. Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8%

Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study details
    Cholangitis
    Pancreatic Cancer
    Choledocholithiasis
    Choledochal Cyst

NCT06111872

National University of Malaysia

13 December 2024

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