Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

Starting soon · Not applicable · Has a placebo group

Conditions studied: Cataract

In brief

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 facts

Study ID

NCT07347886

Run by

Istanbul University - Cerrahpasa

People needed

120

Starts

2026-01-01

Expected to finish

2026-10-01

Last updated by the study team

2026-01-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 50 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Patients scheduled for elective unilateral cataract surgery
• Surgery planned to be performed under topical anesthesia
• Ability to understand the study procedures and provide written informed consent after being fully informed about the study

You may not qualify if…

• Refusal to participate in the study or withdrawal of consent at any stage of the study
• Known intolerance or contraindication to sedative and/or opioid medications
• Presence of significant cardiac arrhythmias
• Severe chronic obstructive pulmonary disease (COPD)
• Hepatic or renal failure
• Inability to cooperate due to cognitive impairment or hearing disability
• Opioid dependence
• Diagnosis of obstructive sleep apnea syndrome (OSAS)
• New York Heart Association (NYHA) class III-IV heart failure
• Conversion to general anesthesia for any reason during surgery

Where it is running

• Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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