Using Ketamine for sedation during ERCP procedures
Official title: Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Run by Universiti Kebangsaan Malaysia Medical Centre · NCT04490031 · Data updated 2026-11-12
This study is testing if Ketamine can be a better sedative than the usual medications during ERCP procedures for patients needing this treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre Academic / other |
| Locations | 1 site (Bandar Tun Razak, Kuala Lumpur) |
| Status | Recruiting |
| Started | March 1, 2020 |
| Main results expected | December 31, 2020 |
| Study ends | April 30, 2021 |
| Registry record updated | July 28, 2020 |
| Trial ID | NCT04490031 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include Malaysian citizens who are scheduled for an ERCP and can provide valid consent.
✕Probably not a fit
Patients with known hypersensitivity to Ketamine or Midazolam, or those with certain medical conditions such as uncontrolled hypertension or recent acute coronary syndrome, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Ketamine as a sedative agent compared to the standard sedation method, which involves Midazolam and Pethidine, during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. It is a double-blinded study where both patients and surgeons are unaware of the sedative agent being used. Patients requiring ERCP at Universiti Kebangsaan Malaysia Medical Centre will be randomly assigned to receive either Ketamine or the standard sedation. Various parameters and outcomes will be measured throughout and after the procedure to assess the efficacy and safety of Ketamine.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective sedation option for patients undergoing ERCP.
How similar studies have gone: While the use of Ketamine in sedation is established, this specific comparison with standard sedation in ERCP is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Malaysian citizens of who is able to give valid consent * Patient planned for ERCP (either emergency or elective) Exclusion Criteria: * 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
Where it's running
-
University Kebangsaan Malaysia Medical center
Bandar Tun Razak, Kuala Lumpur, Malaysia Recruiting
Study contacts
- Principal investigator: Ian Chik, MD — Universiti Kebangsaan Malaysia Medical Centre
- Study coordinator: Muhammad Hafiz Ismail, MBBS
- Email: muhdhafizismail88@gmail.com
- Phone: 6016 3354384
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.