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NCT Number: NCT06111872

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

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

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Key information

Conditions

Cholangitis Bile Duct Diseases Biliary Tract Diseases Choledochal Cyst Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Digestive System Abnormalities Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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:

  • 20-45% failure of sedation during ERCP
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Administration described in arm/ group description

Other names: KETAMINE- MIDAZOLAM

midazolam

Drug

Administration described in arm/ group description

Other names: KETAMINE-MIDAZOLAM

Pethidin

Drug

Administration described in arm/ group description

Other names: MIDAZOLAM-PETHIDIN

Primary outcomes

  1. To compare the depth of sedation

    Time frame: 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

    The depth of sedation is evaluated using ramsay sedation scale where the scale is 1 to 6, where higher score is better

Secondary outcomes

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

    Time frame: 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

    Sedation failure rate is defined as inability of the sedation used to adequately sedate a patient for initiation and completion using ramsay sedation scale where the scale is 1-6, where higher score is better.

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

    Time frame: Measured at specific time-pointswhich are: pre-sedation, 2 minutes after initiation of sedation and 5 minutes after the procedure is completed

    To detect if there are changes in MAP calculated from participants blood pressure readings

  3. 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

    Time frame: Single point asessment at the end of the procedure

    Measured using likert scale

  4. 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

    Time frame: Single point asessment at 2 hours after completion of procedure

    Measured using likert scale

  5. To compare the number of participants that developed an adverse event that led to abandonment of procedure

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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