Oropharyngeoesophageal Topical Anesthesia Prototype Device Versus Intravenous (Propofol -Ketamine Sedation) for Upper Gastrointestinal Endoscopy

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.With regard to the most common sedation regimen used in different countries. In the United States, more than 75% of endoscopists use a benzodiazepine plus narcotic combination, with the combination of midazolam and fentanyl being the most common. A significant percentage of endoscopists (43%) also use propofol regularly, mainly in a hospital setting. In Germany, the most frequently used agents are midazolam (82%) and propofol (74%), and the most common sedation regimens used are propofol plus benzodiazepines (38%) and benzodiazepines plus an opioid (35%). With regard to usage of topical anesthesia during upper gastrointestinal endoscopy, in the United Kingdom it was reported that 63% of endoscopists used topical anesthesia regularly during performance of upper gastrointestinal endoscopy. While twenty percent did not use pharyngeal anesthesia at all, and 17% used pharyngeal anesthesia sometimes. 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. Many studies have compared topical anesthetic agents to other formulations and techniques such as viscous, lozenge, lollipop, and nebulized lidocaine administration. However, it is still unclear which technique is optimal in terms of its influence on the gag reflex, patient tolerability, and pain. Serious allergic reactions were considered to be a risk of local anesthesia in earlier publications, but these are extremely rare. More attention is being paid to the risk of overdosing because lignocaine, the most widely used substance, is a respiratory depressant and an overdose can result in convulsion, hypotension, bradycardia, and even cardiac arrest. As the spray is rapidly absorbed by mucous membranes, the dose should be limited to 200 mg in adults (20 sprays), and in children the limit is 10 sprays. However British Thoracic Society recommends an upper limit of 8.2 mg/kg. The aim of the study is providing 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) .