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Effect of melatonin on anxiety and pain in patient undergoing eye surgery

Effect of preoperative melatonin on anxiety and pain in patient undergoing Phacoemulsification cataract surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/012960
Enrollment
178
Registered
2018-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cataract

Interventions

Intervention1: Melatonin: Tablet melatonin 3mg orally 90 minutes before surgery Control Intervention1: Diazepam: Tablet Diazepam 5mg orally 90 minutes before surgery

Sponsors

Sri Devaraj Urs Academy of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients of either aged 50-80 years 2.Patients undergoing elective Phacoemulsification cataract surgery 3.Patients with American society of Anaesthesiologists (ASA) grade I-II

Exclusion criteria

Exclusion criteria: 1. Patients with sleep disorders, diabetes mellitus, depressive disorder, insufficient pupillary dilatation, nystagmus, deafness, allergy to study drugs, or expected compliance problems due to known psychiatric disease and epilepsy 2. Ongoing treatment with hypnotics, psychotropic drugs, non steroidal anti-inflammatory agents, beta blockers, coumarin derivatives and opioids within a week before admission

Design outcomes

Primary

MeasureTime frame
Decrease in verbal anxiety score (VAS) , verbal pain score (VPS) and sedation scoreTimepoint: Before premedication (T1), 60 minutes after premedication (T2), during the operation period (T3) and also postoperatively before shifting them from the recovery room (T4). Sedation score will be assessed during performance of block.

Secondary

MeasureTime frame
To assess the adverse effects using WHO causality assessment scale Timepoint: 60 minutes after drug administration

Countries

India

Contacts

Public ContactSarala N

Sri Devaraj Urs Medical College

n_sarala@rediffmail.com9845750165

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026