NCT04490031 Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
| NCT ID | NCT04490031 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre |
| Condition | Ketamine Adverse Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2020-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2020-03-01 with a primary completion date of 2020-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.
Eligibility 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
Contact & Investigator
Ian Chik, MD
PRINCIPAL INVESTIGATOR
Universiti Kebangsaan Malaysia Medical Centre
Frequently Asked Questions
Who can join the NCT04490031 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Ketamine Adverse Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04490031 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04490031 currently recruiting?
Yes, NCT04490031 is actively recruiting participants. Contact the research team at muhdhafizismail88@gmail.com for enrollment information.
Where is the NCT04490031 trial being conducted?
This trial is being conducted at Bandar Tun Razak, Malaysia.
Who is sponsoring the NCT04490031 clinical trial?
NCT04490031 is sponsored by Universiti Kebangsaan Malaysia Medical Centre. The principal investigator is Ian Chik, MD at Universiti Kebangsaan Malaysia Medical Centre. The trial plans to enroll 140 participants.