RecruitingPhase 4NCT07036367

The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Sponsor

Al-Azhar University

Enrollment

60 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract Surgery Anesthesia

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether taking melatonin under the tongue (sublingual) before cataract surgery helps reduce anxiety and improves the experience for older patients having the procedure under local anesthesia. **You may be eligible if...** - You are 60 years old or older - You are scheduled for cataract surgery on one eye under local anesthesia - You are in generally good health (ASA physical status I–III) - You can understand and complete study questionnaires **You may NOT be eligible if...** - You have a known allergy to melatonin - You take medications that interact with melatonin - You have significant cognitive impairment or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSublingual 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

DRUGSublingual 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

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NCT07036367

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