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RECRUITINGPhase 4INTERVENTIONAL

The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - • Age ≥ 60 years - American Society of Anesthesiologists (ASA) physical status I-III - Scheduled for unilateral cataract surgery under local anesthesia - Ability to understand and complete study-related questionnaires Who Should NOT Join This Trial: - • Known allergy or hypersensitivity to melatonin - Chronic use of sedatives, hypnotics, or anxiolytics - History of sleep disorders or psychiatric illness - Visual or hearing impairment that would hinder communication - Emergency surgery or anticipated intraoperative complications Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * • Age ≥ 60 years * American Society of Anesthesiologists (ASA) physical status I-III * Scheduled for unilateral cataract surgery under local anesthesia * Ability to understand and complete study-related questionnaires Exclusion Criteria: * • Known allergy or hypersensitivity to melatonin * Chronic use of sedatives, hypnotics, or anxiolytics * History of sleep disorders or psychiatric illness * Visual or hearing impairment that would hinder communication * Emergency surgery or anticipated intraoperative complications

Treatments Being Tested

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