Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

Sponsor
Istanbul University - Cerrahpasa
Study ID
NCT07347886
Status
Not Yet Recruiting

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Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Normal Saline — DRUG
    Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.
  • Midalozam — DRUG
    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) — DRUG
    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.

Study Details

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 Dates

First listed
Jan 16, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Topical anesthesia only (placebo)
    Patients will receive topical anesthesia for cataract surgery. An intravenous placebo (normal saline) will be administered in an identical volume to maintain blinding. No sedative or opioid medication will be given.
  • Experimental: Topical anesthesia + midazolam
    Patients will receive topical anesthesia combined with intravenous midazolam administered for sedation during cataract surgery. The medication will be prepared and administered in a standardized dose and volume to maintain blinding.
  • Experimental: Topical anesthesia + midazolam + fentanyl
    Patients will receive topical anesthesia combined with intravenous midazolam and fentanyl for sedation during cataract surgery. Medications will be administered in standardized doses and equal volumes to ensure blinding across study groups.

Primary Outcome Measure

Patient satisfaction after cataract surgery [ Time Frame: 1 hour postoperatively ]

Central Contacts

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