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NCT06111872CompletedPhase 2

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

Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial

Source: ClinicalTrials.gov · Last updated 25 Mar 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
90 (actual)
First submitted
12 Oct 2023
Start date
18 Jul 2023
Primary completion date
27 Feb 2024
Lead sponsor
National University of Malaysia
NCT number
NCT06111872

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 90
  • From 18 Jul 2023 to the primary completion date, 27 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intravenous drug user (IVDU) or substance abuse patient

Other illness

  • 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)
  • History of hallucination

Other

  • Tachyarrhythmia
  • Pregnancy
  • Child's Pugh class C

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Canselor Tuanku Muhriz UKM
Coordinator of this site? Confirm its status
CherasMalaysiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.