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CholangitisPhase 2NCT06111872

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

A Phase 2 study testing Ketamine, Midazolam and Pethidin in people with Cholangitis and Pancreatic Cancer, run by National University of Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Ketamine, Midazolam and Pethidin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteMalaysia
Study dates
18 Jul 2023to 25 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Intravenous drug user (IVDU) or substance abuse patient
  • History of hallucination
  • Child's Pugh class C

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

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

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

Read the 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.

Being tested
Ketamine, Midazolam, Pethidin
Keywords
Ketamine, Midazolam, sedation, ERCP
Medical subject headings
Cholangitis, Pancreatic Neoplasms, Choledocholithiasis, Choledochal Cyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called KETAMINE- MIDAZOLAM

    Administration described in arm/ group description

  • MidazolamDrug

    Also called KETAMINE-MIDAZOLAM

    Administration described in arm/ group description

  • PethidinDrug

    Also called MIDAZOLAM-PETHIDIN

    Administration described in arm/ group description

Study groups in NCT06111872
Study groupRoleWhat they receive
Ketamine - Midazolam armExperimentalInitial 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
Receives: Drug: Ketamine; Drug: Midazolam
Midazolam - Pethidine armActive comparatorInitial 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.
Receives: Drug: Midazolam; Drug: Pethidin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

Secondary outcomes (5)

  1. 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.

    Measured: 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

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

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

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

  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

    Measured using likert scale

    Measured: Single point asessment at the end of the procedure

  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

    Measured using likert scale

    Measured: Single point asessment at 2 hours after completion of procedure

  5. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start18 Jul 2023
  3. Primary completion27 Feb 2024
  4. Study completion25 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Single blind
Who is masked
Care provider
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111872
Sponsor's protocol ID
JEP-2023-272
Status last verified
Oct 2024
First submitted
12 Oct 2023
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently undecided

Publications

  • Narayanan S, Shannon A, Nandalan S, Jaitly V, Greer S. Alternative sedation for the higher risk endoscopy: a randomized controlled trial of ketamine use in endoscopic retrograde cholangiopancreatography. Scand J Gastroenterol. 2015;50(10):1293-303. doi: 10.3109/00365521.2015.1036113. Epub 2015 Jun 10.

    PubMed 26061267

  • Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.

    PubMed 22144928

  • Jung M, Hofmann C, Kiesslich R, Brackertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam. Endoscopy. 2000 Mar;32(3):233-8. doi: 10.1055/s-2000-96.

    PubMed 10718389

  • Tokmak S, Cetin MF, Torun S. Efficacy and safety of endoscopic retrograde cholangiopancreatography in the very elderly by using a combination of intravenous midazolam, ketamine and pethidine. Geriatr Gerontol Int. 2021 Oct;21(10):887-892. doi: 10.1111/ggi.14252. Epub 2021 Aug 23.

    PubMed 34427037

  • Goudra B, Nuzat A, Singh PM, Borle A, Carlin A, Gouda G. Association between Type of Sedation and the Adverse Events Associated with Gastrointestinal Endoscopy: An Analysis of 5 Years' Data from a Tertiary Center in the USA. Clin Endosc. 2017 Mar;50(2):161-169. doi: 10.5946/ce.2016.019. Epub 2016 Apr 29.

    PubMed 27126387

  • Sadu Singh RS, Azman A, Thanabalan J, Ian C, Sin BH, Jarmin R, Jaafar FF. Combination use of intravenous ketamine-midazolam as a sedative agent in endoscopic retrograde cholangiopancreatography: a randomized control trial. Sci Rep. 2025 Dec 12;16(1):390. doi: 10.1038/s41598-025-29838-x.

    PubMed 41387825

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketamine, Midazolam and Pethidin in people with Cholangitis and Pancreatic Cancer, run by National University of Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111872, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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