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

National University of Malaysia

Status and phase: Completed; Phase 2

Conditions: Choledochal Cyst; Cholangitis; Choledocholithiasis; Pancreatic Cancer

Treatments: Drug: Ketamine; Drug: Pethidin; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06111872

JEP-2023-272

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Ketamine - Midazolam arm

Experimental group

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

Treatment:

Drug: Midazolam

Drug: Ketamine

Midazolam - Pethidine arm

Active Comparator group

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.

Treatment:

Drug: Midazolam

Drug: Pethidin