Sublingual melatonin before cataract surgery in older adults
The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
PHASE4 · Al-Azhar University · NCT07036367
This study will test whether taking sublingual melatonin before cataract surgery helps adults aged 60 and older feel less anxious and sedated while remaining safe.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Al-Azhar University (other) |
| Locations | 2 sites (Cairo, Egypt and 1 other locations) |
| Trial ID | NCT07036367 on ClinicalTrials.gov |
What this trial studies
Adults aged 60 and older scheduled for unilateral cataract surgery under local anesthesia will receive either sublingual melatonin or a matching placebo before the procedure. Eligible participants are ASA physical status I–III and must be able to complete study questionnaires. The trial will record patient-reported anxiety and sedation, as well as objective hemodynamic measures like blood pressure and heart rate and any adverse events. Results will compare anxiety relief, sedation levels, and safety between the melatonin and placebo groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older, ASA I–III, scheduled for unilateral cataract surgery under local anesthesia who are not taking chronic sedatives and can complete study questionnaires.
Not a fit: Patients with a known melatonin allergy, chronic use of sedatives or hypnotics, sleep or psychiatric disorders, significant communication-impairing sensory deficits, emergency surgeries, or anticipated intraoperative complications are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If effective, melatonin could lower preoperative anxiety and reduce the need for stronger sedatives, improving comfort and hemodynamic stability for older cataract patients.
How similar studies have performed: Previous small trials in other surgical settings have suggested melatonin can reduce preoperative anxiety with a favorable safety profile, but its specific use in geriatric cataract surgery is not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo, Egypt and 1 other locations
- Al-Azhar University — Cairo, Egypt, Egypt (NOT_YET_RECRUITING)
- Al-Azhar University — Baghdad, Baghdad Governorate, Iraq (RECRUITING)
Study contacts
- Principal investigator: Neveen A Kohaf, PhD — Al-Azhar University
- Study coordinator: Neveen A Kohaf, PhD
- Email: nevenabdo@azhar.edu.eg
- Phone: +201060383012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract Surgery Anesthesia, Melatonin, Geriatric, Cataract Surgery, Premedication, Sedation, anxiety