Actively Recruiting
The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
Led by Al-Azhar University · Updated on 2026-01-07
60
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the use of sublingual melatonin as a premedication to reduce anxiety and improve sedation in older adults undergoing cataract surgery. The study focuses on comparing the effects of melatonin with a placebo in elderly patients, aiming to maintain safety and minimize changes in blood pressure and heart rate during surgery. Participants are randomly assigned to receive either a 6 mg sublingual melatonin tablet or a placebo tablet one hour before their cataract surgery. Both tablets look identical to maintain blinding. The study involves local anesthesia for the surgery, and the melatonin is given in a form that dissolves quickly under the tongue to ensure proper absorption. During the study, anxiety levels are measured at multiple times before and after the procedure, including 30 and 60 minutes before surgery, during anesthesia application, and 15 and 30 minutes after anesthesia. The study also monitors sedation levels and any hemodynamic changes. Participants complete questionnaires and undergo assessments to provide data on the effects of melatonin compared to placebo, with safety being closely watched throughout the trial.
CONDITIONS
Brief Title
The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- American Society of Anesthesiologists (ASA) physical status I to III
- Scheduled for unilateral cataract surgery under local anesthesia
- Ability to understand and complete study-related questionnaires
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants receive either a 6 mg sublingual tablet of melatonin or a visually identical placebo tablet 60 minutes before cataract surgery to reduce preoperative anxiety and stabilize hemodynamic parameters.
1 preoperative visit (in-person) and surgery day procedures
Duration - Day of surgery
Participants are monitored for anxiety levels and sedation effects at multiple timepoints before and after anesthesia during the surgery day.
Assessments at 30 and 60 minutes before procedure, at local anesthesia application, and 15 and 30 minutes after anesthesia
Trial Site Locations
Total: 2 locations
1
Al-Azhar University
Cairo, Egypt, Egypt, 11865
Not Yet Recruiting
2
Al-Azhar University
Baghdad, Baghdad Governorate, Iraq, 10011
Actively Recruiting
Research Team
N
Neveen A Kohaf, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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