Using Ketamine for sedation during ERCP procedures
Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
PHASE4 · Universiti Kebangsaan Malaysia Medical Centre · NCT04490031
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre (other) |
| Locations | 1 site (Bandar Tun Razak, Kuala Lumpur) |
| Trial ID | NCT04490031 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include Malaysian citizens who are scheduled for an ERCP and can provide valid consent.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bandar Tun Razak, Kuala Lumpur
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ketamine Adverse Reaction