To compare Satisfaction and safety among patients and surgeons of using drug called Dexmedetomidine or Propofol for sedation in addition Ketamine during Endoscopic Retrograde Cholangiopancreatography by doing a Randomized control trial.
Not Applicable
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/08/035358
- Lead Sponsor
- Armed Forces Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
American Society of Anesthesiologists Physical Status (ASA PS) I to III and able to provide informed consent.
Exclusion Criteria
A known allergic reaction to planned medication
A history of unregulated or malignant hypertension
Significant ischemic heart disease
Psychiatric disease
Pregnancy
Seizure disorders
Increased intracranial pressure
Substance abuse or use of drugs that affect the central nervous system.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the patient and endoscopist satisfaction levels as primary objective which will be measured by Patient satisfaction with sedation instrument (PSSI) â?? 20 Items and Clinician satisfaction with sedation instrument (CSSI)-21 Items QuestionnaireTimepoint: Data will be collected 2 Hours after the procedure from patient and immediately after the procedure from the surgeon.
- Secondary Outcome Measures
Name Time Method â?¢Heart rate, Respiratory rate, oxygen saturation <br/ ><br>â?¢Systolic Blood Pressure, Mean arterial Pressure, Diastolic Blood Pressure <br/ ><br>â?¢Bispectral Index Monitoring (BIS Monitoring) during and after surgeryTimepoint: Three Baseline readings of HR, RR, SPO2, SBP, MAP ,DBP and BIS Monitoring will be taken before the procedure and a mean of it will be calculated. <br/ ><br> <br/ ><br>During procedure HR, RR, SPO2, SBP, MAP , DBP and BIS Monitoring will be recorded at five minute interval during procedure and after procedure two readings will be taken at a 15 minute interval and three more readings at a 30 minutes interval thereby monitoring for 2 hours after procedure.