drugset / Trial / NCT07347886

Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

NCT07347886

Not yet recruiting 120 enrolled Istanbul University - Cerrahpasa
RandomizedParallel-groupTriple-blindTreatment

Summary

This study aims to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Cataract surgery is commonly performed under topical anesthesia; however, some patients may experience anxiety, discomfort, or inadequate cooperation during the procedure. Sedation may improve patient comfort and surgical conditions, but it may also be associated with potential adverse effects. In this randomized, prospective study, patients will be assigned to one of three groups: topical anesthesia alone, topical anesthesia combined with midazolam, or topical anesthesia combined with midazolam and fentanyl. Intraoperative sedation levels, hemodynamic parameters, patient satisfaction, and surgeon satisfaction will be assessed and compared among the groups. The results of this study are expected to provide evidence regarding the effectiveness and safety of sedation during cataract surgery performed under topical anesthesia and to help optimize perioperative sedation strategies for these patients.

Timeline

Start
2026-01
Primary completion
2026-07
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified Intravenous
Subject Midazolam Small molecule Intravenous

Indications