The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sublingual Melatonin, Sublingual Placebo.
- Who it may be relevant to
- Registry conditions: Cataract Surgery Anesthesia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt, Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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 dispense - 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 le
Primary outcome measures
- perioperative anxiety [Time frame: at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Al-Azhar University — Cairo
Iraq · 1 center
- Al-Azhar University — Baghdad
Publications
- Wahane VD. A comparison of Gabapentin and melatonin for cataract surgery. Journal of Advanced Medical and Dental Sciences Research. 2017;5(8).
Identifiers
NCT: NCT07036367 · 33/2025