The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

NCT07036367 | Recruiting Phase 4

• 1 other identifier: 33/2025
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Cataract Surgery Anesthesia

Keywords

Melatonin; Geriatric; Cataract Surgery; Premedication; Sedation; anxiety

Outcome Measures

Primary Outcomes (1)

• perioperative anxiety

  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.

Study Arms (2)

Melatonin Group

ACTIVE COMPARATOR

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

Drug: Sublingual Melatonin

Placebo Group

PLACEBO COMPARATOR

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

Drug: Sublingual Placebo

Interventions

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

Melatonin Group

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

Placebo Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Al-Azhar University

Cairo, Egypt, 11865, Egypt

NOT YET RECRUITING

Al-Azhar University

Baghdad, Baghdad Governorate, 10011, Iraq

RECRUITING

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Neveen A Kohaf, PhD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neveen A Kohaf, PhD

CONTACT

+201060383012; nevenabdo@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1); IR (1)