CompletedPhase 2

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

Malaysia90 participantsStarted 2023-07-18

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To compare the depth of sedation

Timeframe: Evaluated at specific timepoints during the procedure whch are: introduction of scope, canulation of bile duct, trawling of stones, removal of stent and removal of scope

Trial details

NCT IDNCT06111872

SponsorNational University of Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-27

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