Protocol for Comparing Benzodiazepine-Ketamine and Benzodiazepine-Fentanyl Sedation in Phacoemulsification (BEKEF): A Double-Blind Crossover Non-Inferiority Clinical Trial Study.

Background: Cataract surgery, particularly phacoemulsification, often requires sedation alongside topical anesthesia to manage patient anxiety and discomfort. This protocol proposes a study comparing the efficacy of ketamine and fentanyl, both combined with benzodiazepine, as sedation options for patients undergoing bilateral phacoemulsification.

Methods: In a randomized, double-blind, crossover clinical trial, at least 48 patients scheduled for bilateral cataract surgery will receive fentanyl with midazolam for one eye and ketamine with midazolam for the other. Sedation levels will be assessed using the Ramsay Sedation Scale, and the SURG-TLX Scale will measure intraoperative difficulties. Secondary outcomes include anesthesia-related complications, pain scores, and patient satisfaction.

Results: The primary outcomes, utilizing the Ramsay Sedation Scale, will determine if ketamine combined with a benzodiazepine is non-inferior to fentanyl combined with a benzodiazepine for sedation during phacoemulsification. Secondary outcomes will provide insight into complications, patient and surgeon comfort, and overall satisfaction.

Conclusion: This trial will evaluate whether ketamine offers a safe and effective alternative to fentanyl for sedation in cataract surgery, potentially optimizing sedation protocols to enhance patient and surgeon experiences.