Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

NCT06111872 | Completed Phase 2 DMC

• 1 other identifier: JEP-2023-272
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholangitis; Pancreatic Cancer; Choledocholithiasis; Choledochal Cyst

Keywords

Ketamine; Midazolam; sedation; ERCP

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• To evaluate the efficacy of Ketamine- Midazolam as a sedative agent in ERCP in terms of sedation failure rate.

  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

• To compare pre and post procedure mean arterial pressure (MAP)

  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

  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

  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

  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

Study Arms (2)

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

Drug: Ketamine; Drug: Midazolam

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.

Drug: Midazolam; Drug: Pethidin

Interventions

Ketamine DRUG

Administration described in arm/ group description

Also known as: KETAMINE- MIDAZOLAM

Ketamine - Midazolam arm

Midazolam DRUG

Administration described in arm/ group description

Also known as: KETAMINE-MIDAZOLAM

Ketamine - Midazolam arm; Midazolam - Pethidine arm

Pethidin DRUG

Administration described in arm/ group description

Also known as: MIDAZOLAM-PETHIDIN

Midazolam - Pethidine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 26061267 BACKGROUND

• 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.

  PMID: 22144928 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.

  PMID: 10718389 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.

  PMID: 34427037 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.

  PMID: 27126387 BACKGROUND

MeSH Terms

Conditions

Cholangitis; Pancreatic Neoplasms; Choledocholithiasis; Choledochal Cyst

Interventions

Ketamine; Midazolam; Meperidine

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Common Bile Duct Diseases; Cholelithiasis; Cysts; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Azlanudin Azman

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 1, 2023
• Study Start: July 18, 2023
• Primary Completion: February 27, 2024
• Study Completion: October 25, 2024
• Last Updated: March 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)