The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Al-Azhar University

Status and phase: Not yet enrolling; Phase 4

Conditions: Cataract Surgery Anesthesia

Treatments: Drug: Sublingual Placebo; Drug: Sublingual Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT07036367

33/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Melatonin Group

Active Comparator group

Description:

a 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery.

Treatment:

Drug: Sublingual Melatonin

Placebo Group

Placebo Comparator group

Description:

the participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery.

Treatment:

Drug: Sublingual Placebo