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RECRUITING
NCT07036367
PHASE4

The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-09-01

Completion Date

2026-06-15

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

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

Locations (2)

Al-Azhar University

Cairo, Egypt, Egypt

Al-Azhar University

Baghdad, Baghdad Governorate, Iraq