Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04490031

Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ketamine Adverse Reaction

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Kebangsaan Malaysia Medical center

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

Location status: Recruiting

Location contact

Azlanudin Azman, MD

PRINCIPAL_INVESTIGATOR

Ian Chik, MD

CONTACT

[email protected]

0123243404

Ian Chik, MD

PRINCIPAL_INVESTIGATOR

Muhammad Hafiz Ismail, MBBS

PRINCIPAL_INVESTIGATOR

Norma Mohamad, MD

PRINCIPAL_INVESTIGATOR

Zamri Zuhdi, MD

CONTACT

[email protected]

6019 2436634

Zamri Zuhdi, MD

PRINCIPAL_INVESTIGATOR

About this study

This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Malaysian citizens of who is able to give valid consent
  • Patient planned for ERCP (either emergency or elective)

Exclusion criteria

  • Known hypersensitivity towards Ketamine or Midazolam
  • Patient refusal to participate or unable to give consent
  • Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
  • Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
  • Acute myocardial infarction, acute coronary syndrome (<3 months)
  • Tachyarrythmia
  • Pregnancy
  • IVDU or substance abuse patient
  • Patient with history of hallucination
  • Child's Pugh Class C

Treatment and study plan

Ketamine Hydrochloride

Drug

patient in Ketamine group will be given Ketamine as sedative agent

Primary outcomes

  1. depth of sedation

    Time frame: 1 hour

    based on Ramsay Sedation Scale, from a scale of 1-6.

    • Patient is anxious and agitated or restless, or both
    • Patient is co-operative, oriented, and tranquil
    • Patient responds to commands only
    • Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
    • Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
    • Patient exhibits no response The aim of sedation is a score of 3-4

  2. completion rate

    Time frame: 1 hour

    to evaluate completion rate between Ketamine and Midazolam group

Secondary outcomes

  1. Surgeon satisfaction score

    Time frame: within 4 hours after completion of ERCP

    subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10.

    0- poor, 5- moderate, 10- excellent

  2. Patient satisfaction score

    Time frame: within 4 hours after completion of ERCP

    subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.

    0- poor, 5- moderate, 10- excellent

  3. evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms

    Time frame: 24 hours

    recording the adverse events of each sedation.

    • Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg
    • Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg
    • Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute
    • Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute
    • Hypoxia: defined by oxygen saturation less than 95%
    • Respiratory rate abnormality
    • Nausea, vomiting, emergence symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Ian Chik, MD

CONTACT

[email protected]

6012 3243404

Muhammad Hafiz Ismail, MBBS

CONTACT

[email protected]

6016 3354384

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
Jul 28, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.