The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

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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Key information

Conditions

Cataract Surgery Anesthesia Anxiety Disorders Mental Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al-Azhar University, Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

perioperative anxiety

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neveen A Kohaf, PhD

CONTACT

[email protected]

+201060383012

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 25, 2025
Registry last updated: Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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