The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
Al-Azhar University
60 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- • 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 Criteria5
- • 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
Interventions
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
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)
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NCT07036367