The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

January 4, 2026 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Egypt
      • Cairo, Egypt, Egypt, 11865
        • Not yet recruiting
        • Al-Azhar University
        • Principal Investigator:
          • Haider Hamza, M.D
        • Contact:
        • Contact:
  • Iraq
    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Iraq, 10011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin Group
a 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery.
Drug: 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
Placebo Comparator: Placebo Group
the participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Neveen A Kohaf, PhD, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Wahane VD. A comparison of Gabapentin and melatonin for cataract surgery. Journal of Advanced Medical and Dental Sciences Research. 2017;5(8).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

June 14, 2025

First Submitted That Met QC Criteria

June 24, 2025

First Posted (Actual)

June 25, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon reasonable request from the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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