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Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia
Sponsor: Istanbul University - Cerrahpasa
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.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-01
Completion Date
2026-10
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Normal Saline
Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.
Midalozam
Intravenous midazolam administered for procedural sedation during cataract surgery performed under topical anesthesia. The medication will be prepared and administered in standardized doses and identical volumes to maintain blinding.
Fentanyl (IV)
intravenous fentanyl administered in combination with midazolam to provide analgesia and sedation during cataract surgery under topical anesthesia. The medication will be prepared and administered in standardized doses and equal volumes to ensure blinding across study groups.
Locations (1)
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
Istanbul, Turkey (Türkiye)