About this trial
It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients of both genders
Age between 18 and 85 years old
Referred to standard upper endoscopy at Luzmila Hospital
Disqualifiers
Patients who are pregnant,
Known allergies to the used drugs
History of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension)
Previous history of gastrectomy,
Trial design
Parallel
Treatments tested in this trial
Propofol 100 MG in 10 ML Injection
DrugSedation induction time (minutes), total dose of propofol (mg), recovery time (minutes), any involuntary patient movement, quality of sedation (VAS) and adverse events
Treatment groups
Trial outcomes
Primary outcomes
Sedation induction time (minutes)
Sedation induction time (minutes) is the time measured from the deep sedation induction until the patient is deeply sedated
Total dose of propofol (mg)
Total dose of propofol (mg) used during the upper endoscopy procedure
Recovery time (minutes)
Recovery time (minutes) is the time used for the patients to open their eyes after stoping sedation
Secondary outcomes
Involuntary movement
Any involuntary patient movement during the endoscopy procedure under deep sedation
Quality of sedation
How deeply is the patient sedated (VAS) as assessed by the endoscopist (1 good, 2 moderate, 3 poor)
Adverse events
Any adverse events occurring during the procedure such as apnea, dyspnea, hiccups, jerky movements...etc
Locations
Sponsors and contacts
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Al-Balqa Applied University
Lead sponsor
Luzmila Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: