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

National University of Malaysia (UKM)

Status and phase

Enrolling

Phase 4

Conditions

Ketamine Adverse Reaction

Treatments

Drug: Ketamine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT04490031

Hukm

Details and patient eligibility

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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