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New treatment option for Ketamine Adverse Reaction
Official title Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
ClinicalTrials.gov ID: NCT04490031
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, being studied as a potential treatment for ketamine adverse reaction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older. Healthy volunteers may be eligible.
You may be able to join if
- Malaysian citizens of who is able to give valid consent
- Patient planned for ERCP (either emergency or elective)
You likely can't join if
- 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
See the full eligibility criteria
- Malaysian citizens of who is able to give valid consent
- Patient planned for ERCP (either emergency or elective)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bandar Tun Razak, Kuala Lumpur, Malaysia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bandar Tun Razak, Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.