The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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Prevalence of anesthesia care during cataract surgery compared with other low-risk procedures; association of anesthesia care with patient, clinician, and health system characteristics; and proportion of patients experiencing a significant anxiety and hemodynamic instability during cataract surgery.

Conditions

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Cataract Surgery Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Melatonin Group

a 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery.

Group Type ACTIVE_COMPARATOR

Sublingual Melatonin

Intervention Type 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

Placebo Group

the participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery.

Group Type PLACEBO_COMPARATOR

Sublingual Placebo

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No