NCT07036367

The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Cataract surgery is routinely performed with anesthesia care, whereas anesthesia care for other elective, low-risk, outpatient procedures is applied more selectively. We hypothesize that sublingual melatonin will provide superior anxiolysis and sedation while maintaining a high safety profile and minimizing hemodynamic disturbances.

Detailed description

Prevalence of anesthesia care during cataract surgery compared with other low-risk procedures; association of anesthesia care with patient, clinician, and health system characteristics; and proportion of patients experiencing a significant anxiety and hemodynamic instability during cataract surgery.

Conditions

• Cataract Surgery Anesthesia

Interventions

Type	Name	Description
DRUG	Sublingual Melatonin	Participants in this group received 3 mg of sublingual melatonin, administered 60 minutes before cataract surgery. The melatonin was given in the form of a rapidly dissolving sublingual tablet to enhance bioavailability and ensure consistent preoperative absorption. The goal of the intervention was to reduce preoperative anxiety, improve sedation level, and stabilize hemodynamic parameters. The melatonin tablets were indistinguishable in appearance from the placebo and were prepared and dispensed by a pharmacy technician not involved in data collection or patient care
DRUG	Sublingual Placebo	Participants in this group received an identical-appearing sublingual placebo tablet containing inert ingredients, administered 60 minutes before cataract surgery. The placebo was visually indistinguishable from the melatonin tablets and was used to maintain double blinding in the trial. Tablets were prepared by the pharmacy team to ensure concealment and eliminate bias. This group was designed to serve as a control to evaluate the effectiveness of sublingual melatonin on anxiety and sedation levels in elderly patients

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-15
• Completion: 2026-06-15
• First posted: 2025-06-25
• Last updated: 2026-01-07

Locations

2 sites across 2 countries: Egypt, Iraq