Cataract Surgery Anesthesia
Conditions
Keywords
Melatonin, Geriatric, Cataract Surgery, Premedication, Sedation, anxiety
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.
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
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
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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| perioperative anxiety | at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia. | It will be assessed using the Visual Analog Scale (VAS) for anxiety (0-10 cm) upon arrival to the operating room. |
Countries
Egypt, Iraq
Contacts
Primary ContactNeveen A Kohaf, PhD
Outcome results
None listed