Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography: Randomized Single Blinded Controlled Study

MS-211-2023

The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.

2023-09-01

2024-01-01

2024-02-01

Completed

202

Inclusion Criteria: * Age starting from 21 to 60 years. * Genders eligible for study: males and females * ASA II-III * Undergoing ERCP * 18.5 to 30 kg/m2 Exclusion Criteria: * Patient refusal * Known allergy to drugs used in the study. * Use of any anti-coagulants * Neurological disorders * Advanced liver or kidney disease * Patient with psychiatric disorders

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* To compare hemodynamic profile of dexmedetomidine and Propfol during sedation in patients undergoing ERCP.\n* To study both agents effect on respiratory complications.\n* To demonstrate the effect of both drugs on cognitive functions.\n* To assess the effect of both drugs on duration of procedure and number of interruptions.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 101 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 202, 'type': 'ACTUAL'}}

2024-05-14