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Clinical trial

Comparison of Propofol-Nalbuphine and Propofol-Magnesium Sulphate Sedation for Patients Undergoing GIT Endoscopy

ID
Name
ERCP
Description
Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-11-01
Trial end
2024-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
propofol and magnesium sulphate ,propofol and nalbuphine
The patients will be randomly divided into 2 groups by using a computer-generated randomization tableAll patients will fast from solids for 8 h and from liquids for 2 h. After arrival at preoperative area an intravenous cannula will be placed in the peripheral vein of right hand for fluid infusion and medicine administration. All of the patients will be interviewed by the patient sedation satisfaction assessment tool (PSSI) regarding their experience 1 hour after the operation.
Arms:
Propofol and magnesium sulfate group, propofol and nalbuphine group
Size
60
Primary endpoint
The level of patient sedation
the time of endoscopy
Eligibility criteria
Inclusion Criteria: * 1. Patients scheduled for GIT endoscopy 2. Age 18-60 years old 3. ASA I-II. 4. BMI less than 30 Exclusion Criteria: * 1. Heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) 2. pulmonary disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, or lung cancer) 3. central nervous system abnormality 4. allergy to the study drugs 5. habitual sedative or analgesic use 6. pregnancy 7. Anticipated difficult airway.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-08-16

1 organization

1 product

1 indication

Organization
Assiut University
Product
Propofol
Indication
Gastrointestinal Endoscopy