Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- depth of sedation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Care Provider)
Masking Description
Both the patients and surgeon will be blinded from knowing the sedative agent
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Ketamine group
Intervention: Ketamine Hydrochloride (Drug)
Outcomes
Primary Outcomes
depth of sedation
Time Frame: 1 hour
based on Ramsay Sedation Scale, from a scale of 1-6. 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response The aim of sedation is a score of 3-4
completion rate
Time Frame: 1 hour
to evaluate completion rate between Ketamine and Midazolam group
Secondary Outcomes
- Surgeon satisfaction score(within 4 hours after completion of ERCP)
- Patient satisfaction score(within 4 hours after completion of ERCP)
- evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms(24 hours)