Clinical trial NCT06111872: Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.
Official title: Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangitis
Pancreatic Cancer
Choledocholithiasis
Choledochal Cyst
Keywords: Ketamine
Midazolam
sedation
ERCP
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?

Detailed description: 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:

1. 20-45% failure of sedation during ERCP
2. Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8%

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the depth of sedation
timeFrame: 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
Secondary outcomes:
measure: To evaluate the efficacy of Ketamine- Midazolam as a sedative agent in ERCP in terms of sedation failure rate.
timeFrame: 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
measure: To compare pre and post procedure mean arterial pressure (MAP)
timeFrame: Measured at specific time-pointswhich are: pre-sedation, 2 minutes after initiation of sedation and 5 minutes after the procedure is completed
measure: 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
timeFrame: Single point asessment at the end of the procedure
measure: 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
timeFrame: Single point asessment at 2 hours after completion of procedure
measure: To compare the number of participants that developed an adverse event that led to abandonment of procedure
timeFrame: 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
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz UKM
state: Kuala Lumpur
Study officials:
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Azlanudin Azman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.