Clinical trial

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

Name

JEP-2023-272

Description

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

Trial arms

Trial start

2023-07-18

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Recruiting

Phase

Early phase I

Treatment

Ketamine

Administration described in arm/ group description

Arms:

Ketamine - Midazolam arm

Other names:

KETAMINE- MIDAZOLAM

Midazolam

Administration described in arm/ group description

Arms:

Ketamine - Midazolam arm, Midazolam - Pethidine arm

Other names:

KETAMINE-MIDAZOLAM

Pethidin

Administration described in arm/ group description

Arms:

Midazolam - Pethidine arm

Other names:

MIDAZOLAM-PETHIDIN

Size

Primary endpoint

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 which are: introduction of scope, canulation of bile duct, during sphincerotomy, trawling of stones, removal of stent and removal of scope

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Care provider is blinded from knowing the group of the study. However patients are informed regarding the drugs received', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

2 products

1 drug

4 indications

Organization

National University of Malaysia

Drug

Ketamine

Indication

Cholangitis