The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery

Phase 4

Not yet recruiting

• Conditions: Cataract Surgery Anesthesia
• Interventions: Drug: Sublingual Melatonin; Drug: Sublingual Placebo

• Registration Number: NCT07036367
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-14
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-07-01
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin Group	Sublingual Melatonin	a 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery.
Placebo Group	Sublingual Placebo	the participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt