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Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?
Ketamine- Midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ERCP compared to Midazolam- Pethidine. The usage of sedative agent in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to:
Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine - Midazolam arm | Experimental | Initial IV Ketamine of 0.5mg/kg with IV Midazolam 0.02mg/kg given over 1 minute. If depth of sedation not adequate, to give another bolus of IV ketamine 0.25mg/kg after 2 minutes with IV Midazolam 0.01mg/kg. If depth of sedation not adequate, to give another bolus of IV Ketamine 0.25mg/kg after 2 minutes and IV Midazolam 0.01mg/kg. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team |
|
| Midazolam - Pethidine arm | Active Comparator | Initial IV Midazolam 0.05mg/kg given over 1 minute with IV Pethidine 0.7mcg/kg. If depth of sedation not If adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes and IV Pethidine 0.7mcg/kg. If depth of sedation not adequate, to give another bolus of IV Midazolam 0.02mg/kg after 2 minutes. Failure of sedation: inadequate sedation for the intention to treat: patient will be arranged for MAC (monitored anaesthesia care) with anaesthesia team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Administration described in arm/ group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the depth of sedation | The depth of sedation is evaluated using ramsay sedation scale where the scale is 1 to 6, where higher score is better | Evaluated at specific timepoints during the procedure whch are: introduction of scope, canulation of bile duct, trawling of stones, removal of stent and removal of scope |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of Ketamine- Midazolam as a sedative agent in ERCP in terms of sedation failure rate. | Sedation failure rate is defined as inability of the sedation used to adequately sedate a patient for initiation and completion using ramsay sedation scale where the scale is 1-6, where higher score is better. | Evaluated at specific timepoints during the procedure whch are: introduction of scope, canulation of bile duct, during sphincerotomy, removal of stent and removal of scope |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Azlanudin Azman | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tuanku Muhriz UKM | Cheras | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26061267 | Background | Narayanan S, Shannon A, Nandalan S, Jaitly V, Greer S. Alternative sedation for the higher risk endoscopy: a randomized controlled trial of ketamine use in endoscopic retrograde cholangiopancreatography. Scand J Gastroenterol. 2015;50(10):1293-303. doi: 10.3109/00365521.2015.1036113. Epub 2015 Jun 10. | |
| 22144928 | Background |
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Currently undecided
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D010190 | Pancreatic Neoplasms |
| D042883 | Choledocholithiasis |
| D015529 | Choledochal Cyst |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008874 | Midazolam |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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Patients will be randomized into the intervention or control group (Intervention group will receive Ketamine - Midazolam and control group will receive Midazolam- Pethidine as a sedative agent in ERCP
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Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received
| Midazolam | Drug | Administration described in arm/ group description |
|
|
| Pethidin | Drug | Administration described in arm/ group description |
|
|
| To compare pre and post procedure mean arterial pressure (MAP) | To detect if there are changes in MAP calculated from participants blood pressure readings | Measured at specific time-pointswhich are: pre-sedation, 2 minutes after initiation of sedation and 5 minutes after the procedure is completed |
| To compare surgeon satisfaction in terms of sedation quality between both arms using a likert scale of 1 to 5 where a higher score is better | Measured using likert scale | Single point asessment at the end of the procedure |
| To compare participant satisfaction in terms of procedure experience between both groups using likert scale of 1 to 10 where the higher score is better | Measured using likert scale | Single point asessment at 2 hours after completion of procedure |
| To compare the number of participants that developed an adverse event that led to abandonment of procedure | Adverse event by monitoring patient vital signs including blood pressure, pulse rate, oxygen saturation and procedure will be abandoned if the parameters reach a pre-set cut-off point. Systolic blood pressure <90mmHg or >180mmHg, Pulse rate of <60/min or >150/min and oxygen saturation <95% despite supplemental oxygen therapy via nasal canula. | Evaluated at specific timepoints during the procedure which are: introduction of scope, canulation of bile duct, during sphincerotomy, trawling of stones, removal of stent and removal of scope |
| Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270. |
| 10718389 | Background | Jung M, Hofmann C, Kiesslich R, Brackertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam. Endoscopy. 2000 Mar;32(3):233-8. doi: 10.1055/s-2000-96. |
| 34427037 | Background | Tokmak S, Cetin MF, Torun S. Efficacy and safety of endoscopic retrograde cholangiopancreatography in the very elderly by using a combination of intravenous midazolam, ketamine and pethidine. Geriatr Gerontol Int. 2021 Oct;21(10):887-892. doi: 10.1111/ggi.14252. Epub 2021 Aug 23. |
| 27126387 | Background | Goudra B, Nuzat A, Singh PM, Borle A, Carlin A, Gouda G. Association between Type of Sedation and the Adverse Events Associated with Gastrointestinal Endoscopy: An Analysis of 5 Years' Data from a Tertiary Center in the USA. Clin Endosc. 2017 Mar;50(2):161-169. doi: 10.5946/ce.2016.019. Epub 2016 Apr 29. |
| 41387825 | Derived | Sadu Singh RS, Azman A, Thanabalan J, Ian C, Sin BH, Jarmin R, Jaafar FF. Combination use of intravenous ketamine-midazolam as a sedative agent in endoscopic retrograde cholangiopancreatography: a randomized control trial. Sci Rep. 2025 Dec 12;16(1):390. doi: 10.1038/s41598-025-29838-x. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003137 | Common Bile Duct Diseases |
| D002769 | Cholelithiasis |
| D003560 | Cysts |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |