Comparison of Dexmedetomidine Versus Ketofol For Moderate Sedation In Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial

234

Patients were randomly divided into Dexmedetomidine or Ketofol for sedation. In patients who received Dexmedetomidine, a 2ml ampule of 100 ug/ml was diluted in 18 ml of normal saline, making a total volume of 20 ml. Patients received dexmedetomidine as a bolus over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr and it was labeled as "infusion 1". In the Ketofol group, 2 ml ketamine (50mg/ml) and 10 ml of propofol 1% (10mg/ml) were diluted in 8ml of normal saline. This mixture was 20 ml each, making 5mg/ml of ketamine and propofol. Patients received 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion, labeled as "infusion 2".

2021-12-01

2022-06-30

2022-06-30

Completed

Early phase I

62

Inclusion Criteria: * Aged 20-60 years * Any gender * Scheduled for elective ERCP * American Society of Anesthesiologists (ASA) classification I or II Exclusion Criteria: * Allergic to dexmedetomidine, Ketofol, or related medications * BMI over 36 kg/m2 (morbidly obese) * History of stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, hypothyroidism, and congestive cardiac failure

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ACTUAL'}}

2024-01-18