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

Phase 4

Recruiting

• Conditions: Ketamine Adverse Reaction
• Interventions: Drug: Ketamine Hydrochloride

• Registration Number: NCT04490031
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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 Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-01
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Study First Posted: 2020-07-28
• Last Update Posted: 2020-07-28
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketamine group	Ketamine Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
depth of sedation	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	1 hour	to evaluate completion rate between Ketamine and Midazolam group

Secondary Outcome Measures

Name	Time	Method
Surgeon satisfaction score	within 4 hours after completion of ERCP	subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10.; 0- poor, 5- moderate, 10- excellent
Patient satisfaction score	within 4 hours after completion of ERCP	subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.; 0- poor, 5- moderate, 10- excellent
evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms	24 hours	recording the adverse events of each sedation.; 1. Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg; 2. Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg; 3. Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute; 4. Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute; 5. Hypoxia: defined by oxygen saturation less than 95%; 6. Respiratory rate abnormality; 7. Nausea, vomiting, emergence symptoms

Trial Locations

Locations (1)

University Kebangsaan Malaysia Medical center; 🇲🇾 Bandar Tun Razak, Kuala Lumpur, Malaysia