Clinical trial · Interventional
Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.
Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial
NCT06111872CI-TRIAL-00087622completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangitis | — | UNRESOLVED | — |
| Choledochal Cyst | — | UNRESOLVED | — |
| Choledocholithiasis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Pethidin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketamine - Midazolam arm
- description
- 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
- interventionNames
- Drug: Ketamine
- Drug: Midazolam
- type
- ACTIVE_COMPARATOR
- label
- Midazolam - Pethidine arm
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \> 18 years old which able to give valid consent * Patient planned for ERCP (either emergency or elective) * American Society of Anaesthesiologist (ASA) score of I-III Exclusion Criteria: * Known hypersensitivity towards Ketamine or Midazolam * Increased intracranial pressure, acute stroke (\<3 months), intracranial haemorrhage (\<3 months) * Severe hypertension (BP\>170/110) and tachycardia (Heart rate \>110) * Acute myocardial infarction, acute coronary syndrome (\< 6 months) * Tachyarrhythmia * Pregnancy * Intravenous drug user (IVDU) or substance abuse patient * History of hallucination * Child's Pugh class C
References
Publications (6)
- BACKGROUNDNarayanan 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. PMID 26061267
- BACKGROUNDTobias 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. PMID 22144928
- BACKGROUNDJung 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. PMID 10718389
- BACKGROUNDTokmak 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. PMID 34427037
- BACKGROUNDGoudra 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. PMID 27126387
- DERIVEDSadu 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. PMID 41387825