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Recruiting NCT04490031

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

Phase IV Interventional Ketamine Adverse Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine Hydrochloride.
Who it may be relevant to
Registry conditions: Ketamine Adverse Reaction. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug Ketamine Hydrochloride
    patient in Ketamine group will be given Ketamine as sedative agent

Primary outcome measures

  • depth of sedation [Time frame: 1 hour]
  • completion rate [Time frame: 1 hour]
Secondary outcome measures (3)
  • Surgeon satisfaction score [Time frame: within 4 hours after completion of ERCP]
  • Patient satisfaction score [Time frame: within 4 hours after completion of ERCP]
  • evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Health services research

Study locations

Malaysia · 1 center
  • University Kebangsaan Malaysia Medical center — Bandar Tun Razak

Identifiers

NCT: NCT04490031 · Hukm

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗