Clinical trial NCT04490031: Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ketamine Adverse Reaction
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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

Primary outcomes:
measure: depth of sedation
timeFrame: 1 hour
measure: completion rate
timeFrame: 1 hour
Secondary outcomes:
measure: Surgeon satisfaction score
timeFrame: within 4 hours after completion of ERCP
measure: Patient satisfaction score
timeFrame: within 4 hours after completion of ERCP
measure: evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: University Kebangsaan Malaysia Medical center
state: Kuala Lumpur
Study officials:
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Ian Chik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Norma mohamad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Zamri Zuhdi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Azlanudin Azman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Muhammad Hafiz Ismail, MD
role: PRINCIPAL_INVESTIGATOR
References: