Ketamine Adverse Reaction
Conditions
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.
Interventions
DRUGKetamine Hydrochloride
patient in Ketamine group will be given Ketamine as sedative agent
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Masking description
Both the patients and surgeon will be blinded from knowing the sedative agent
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Malaysia
Contacts
Primary ContactMuhammad Hafiz Ismail, MBBS
Backup ContactIan Chik, MD
Outcome results
None listed