Oropharyngeoesophageal Topical Anesthesia Versus Propofol - Ketamine Sedation for Upper Gastrointestinal Endoscopy
NCT Number: NCT06566326
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Upper Gastrointestinal Endoscopy|Topical Anesthesia|Intravenous Sedation
Sponsor: Zagazig University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-07-30

Summary:
Esophagogastroduodenoscopy (EGD) is an essential and widely used diagnostic and therapeutic procedure in gastroenterology. EGD can be performed in association with topical anesthesia of the pharynx, intravenous anesthesia, or with their combination. Sedation is required to alleviate anxiety, provide analgesia, amnesia and to improve endoscopic performance specifically in therapeutic procedures. However, sedation-related gastrointestinal endoscopy complications when occur, may lead to significant morbidity and occasional mortality especially with moderate and deep sedation. Cardiopulmonary complications resulting from aspiration, oversedation, hypoventilation, vasovagal reflex, and airway obstruction account for more than 50% of all complications associated with upper endoscopy. Topical pharyngeal anesthesia currently is a requirement for upper endoscopy to provide patients with the best comfort in unsedated EGD. In Hong Kong, 10% Xylocaine pump spray (AstraZeneca, Sodertalje, Sweden) is the pharyngeal anesthesia generally used as a premedication in unsedated EGD. The aim of this study was to provide more effective, safer, tolerable and offers quicker recovery technique using either the modified Oropharyngeoesophageal Topical Anesthesia (OPETA) technique or conventional intravenous sedation by prepared mixture of propofol and ketamine (ketofol 4:1) .

Primary Outcome Measures: Patient discomfort felt during endoscopy, 0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable., Endoscopy time: Time from starting of insertion till removal of the endoscope
Secondary Outcome Measures: Difficulty in insertion of OPETA device, 0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable., OPETA time: Time from administration of self or helped oral topical anesthesia till getting the OPETA device manipulation tolerated by the patient (moving the OPETA tool up and down clockwise and anti-clockwise without distressing the patient).|Difficulty in introducing the endoscope, 0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable., Endoscopy time: Time from starting of insertion till removal of the endoscope|Overall technical difficulty of the examination, 0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable., Endoscopy time: Time from starting of insertion till removal of the endoscope