The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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

Primary outcome measure(s)

• perioperative anxiety — at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.
  It will be assessed using the Visual Analog Scale (VAS) for anxiety (0-10 cm) upon arrival to the operating room.

Trial sites (2)

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