A Phase 2 interventional study of Ketamine and Midazolam in Cholangitis, Pancreatic Cancer and Choledocholithiasis, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by National University of Malaysia · Phase 2, Interventional, and Treatment
Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?
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:
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.
82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.
This study's enrollment of 90 is close to the median of 100 across 52 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Ketamine · Drug: Midazolam
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.
Drug: Midazolam · Drug: Pethidin
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
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
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 using ramsay sedation scale where the scale is 1-6, where higher score is better.
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
To compare pre and post procedure mean arterial pressure (MAP)
To detect if there are changes in MAP calculated from participants blood pressure readings
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 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
Time frame: Single point asessment at the end of the procedure
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
Time frame: Single point asessment at 2 hours after completion of procedure
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.
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
Plan to share: No — Currently undecided
Ran from Jul 2023 to primary completion in Feb 2024, 7 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
National University of Malaysia →