RecruitingPhase 4NCT04490031

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

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


Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Enrollment

140 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 Years

Inclusion Criteria2

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

Exclusion Criteria10

  • 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

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Interventions

DRUGKetamine Hydrochloride

patient in Ketamine group will be given Ketamine as sedative agent


Locations(1)

University Kebangsaan Malaysia Medical center

Bandar Tun Razak, Kuala Lumpur, Malaysia

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NCT04490031