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

Pancreatic Cancer Clinical Trial

Official title:

Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111872
• Other study ID #: JEP-2023-272
• Status: Recruiting
• Phase: Phase 2
• Start date: July 18, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: National University of Malaysia
• Contact: Rajdave Singh
• Phone: +60102200836
• Email: rajdavee.s[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Choledochal Cyst
• Choledocholithiasis
• Pancreatic Cancer

Intervention

Drug:
• Ketamine
Administration described in arm/ group description
• Midazolam
Administration described in arm/ group description
• Pethidin
Administration described in arm/ group description

Locations

Country	Name	City	State
Malaysia	Hospital Canselor Tuanku Muhriz UKM	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 of procedure using ramsay sedation scale where the scale is 1 to 6, where higher score is better. Score of 1 is determined as sedation failure.	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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, during sphincerotomy, trawling of stones, removal of stent and removal of scope