Actively Recruiting

Phase 4
Age: 16Years +
All Genders
Healthy Volunteers
NCT04490031

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

Led by Universiti Kebangsaan Malaysia Medical Centre · Updated on 2020-07-28

140

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Malaysian citizens who are able to give valid consent
  • Patients planned for ERCP (either emergency or elective)
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to 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)
  • Tachyarrhythmia
  • Pregnancy
  • Intravenous drug use or substance abuse
  • History of hallucination
  • Child-Pugh Class C

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Kebangsaan Malaysia Medical center

Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000

Actively Recruiting

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Research Team

M

Muhammad Hafiz Ismail, MBBS

CONTACT

I

Ian Chik, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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