To hear about similar clinical trials, please enter your email below
Trial Title:
Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.
NCT ID:
NCT06111872
Condition:
Cholangitis
Pancreatic Cancer
Choledocholithiasis
Choledochal Cyst
Conditions: Official terms:
Choledochal Cyst
Cholangitis
Choledocholithiasis
Midazolam
Meperidine
Ketamine
Conditions: Keywords:
Ketamine
Midazolam
sedation
ERCP
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Care Provider)
Masking description:
Care provider is blinded from knowing the group of the study. However patients are
informed regarding the drugs received
Intervention:
Intervention type:
Drug
Intervention name:
Ketamine
Description:
Administration described in arm/ group description
Arm group label:
Ketamine - Midazolam arm
Other name:
KETAMINE- MIDAZOLAM
Intervention type:
Drug
Intervention name:
Midazolam
Description:
Administration described in arm/ group description
Arm group label:
Ketamine - Midazolam arm
Arm group label:
Midazolam - Pethidine arm
Other name:
KETAMINE-MIDAZOLAM
Intervention type:
Drug
Intervention name:
Pethidin
Description:
Administration described in arm/ group description
Arm group label:
Midazolam - Pethidine arm
Other name:
MIDAZOLAM-PETHIDIN
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Canselor Tuanku Muhriz UKM
Address:
City:
Cheras
Zip:
56000
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Rajdave Singh
Phone:
0102200836
Email:
rajdavee.s@gmail.com
Investigator:
Last name:
Azlanudin Azman
Email:
Principal Investigator
Investigator:
Last name:
Ian Chik
Email:
Sub-Investigator
Investigator:
Last name:
Jegan Thanabalan
Email:
Sub-Investigator
Investigator:
Last name:
Kanesh Kumar Doraisamy
Email:
Sub-Investigator
Start date:
July 18, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
National University of Malaysia
Agency class:
Other
Source:
National University of Malaysia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06111872
