The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

ConditionCataract Surgery Anesthesia

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age60+

SponsorAl-Azhar University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

Sublingual Melatonin
Drug
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
Sublingual Placebo
Drug
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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Melatonin GroupActive comparator 1 intervention

Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

perioperative anxiety

It will be assessed using the Visual Analog Scale (VAS) for anxiety (0-10 cm) upon arrival to the operating room.

Time frame

at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

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