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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.
This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam group | No Intervention | Standard sedation for ERCP in UKMMC | |
| Ketamine group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | patient in Ketamine group will be given Ketamine as sedative agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| depth of sedation | based on Ramsay Sedation Scale, from a scale of 1-6.
| 1 hour |
| completion rate | to evaluate completion rate between Ketamine and Midazolam group | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon satisfaction score | subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent | within 4 hours after completion of ERCP |
| Patient satisfaction score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Hafiz Ismail, MBBS | Contact | 6016 3354384 | muhdhafizismail88@gmail.com | |
| Ian Chik, MD | Contact | 6012 3243404 | ianchikmd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ian Chik, MD | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Norma mohamad, MD | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Kebangsaan Malaysia Medical center | Recruiting | Bandar Tun Razak | Kuala Lumpur | 56000 | Malaysia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 11, 2023 | Feb 7, 2023 | 1 | ||
| Aug 27, 2023 |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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Both the patients and surgeon will be blinded from knowing the sedative agent
subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.
0- poor, 5- moderate, 10- excellent
| within 4 hours after completion of ERCP |
| evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms | recording the adverse events of each sedation.
| 24 hours |
| Zamri Zuhdi, MD |
| Universiti Kebangsaan Malaysia Medical Centre |
| Principal Investigator |
| Azlanudin Azman, MD | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Muhammad Hafiz Ismail, MD | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Sep 20, 2023 |
| 2 |
| Jan 25, 2024 | Feb 20, 2024 | 3 |
| Apr 5, 2024 | Apr 5, 2024 | 4 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |