NCT07036367 The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
| NCT ID | NCT07036367 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Al-Azhar University |
| Condition | Cataract Surgery Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Neveen A Kohaf, PhD
PRINCIPAL INVESTIGATOR
Al-Azhar University
Frequently Asked Questions
Who can join the NCT07036367 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Cataract Surgery Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07036367 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07036367 currently recruiting?
Yes, NCT07036367 is actively recruiting participants. Contact the research team at nevenabdo@azhar.edu.eg for enrollment information.
Where is the NCT07036367 trial being conducted?
This trial is being conducted at Cairo, Egypt, Baghdad, Iraq.
Who is sponsoring the NCT07036367 clinical trial?
NCT07036367 is sponsored by Al-Azhar University. The principal investigator is Neveen A Kohaf, PhD at Al-Azhar University. The trial plans to enroll 60 participants.