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

Not Applicable

Recruiting

• Conditions: Cataract

• Registration Number: CTRI/2018/04/012960
• Lead Sponsor: Sri Devaraj Urs Academy of Higher Education and Research

Brief Summary

Need for the study

Drugs such as propofol, benzodiazepines, opioids and dexmedetomedine have been used for sedation and pain during Phacoemulsification cataract surgery.1 Benzodiazepines are commonly used to alleviate anxiety but may impair psychomotor performance and suppress the duration of rapid eye movement sleep.2 Propofol and opioids cause sedation, disorientation and respiratory depression, dexmedetomedine may lead to hypotension, bradycardia and cardiovascular depression.3 In addition the cognitive function is impaired which is undesirable during cataract surgery, thus these limitations lead to impairment in patient’s co-operation during surgery. Therefore, the need for a drug that relieves anxiety and pain without causing cognitive dysfunction is desirable.

Melatonin is secreted by the pineal gland in the dark and inhibited by exposure to light. Oral administration of 1–5 mg of melatonin results in plasma levels of 10–100 times more than the observed endogenous night-time levels.4 Melatonin has sedative, analgesic, antioxidative and anti-inflammatory property.5 Intraocular pressure (IOP) is higher during daytime than at night and it has been suggested that melatonergic mechanisms in the eyes could be responsible for the diurnal rhythm in IOP. Melatonin can cause adverse effects like drowsiness, headache, gastrointestinal disturbances and rash.6 It does not produce residual effects or suppression of rapid eye movement sleep. Melatonin 3-10mg oral has been approved by CDSCO for use in India on 12/03/1998 to treat sleep disorder, jet lag and regulation of circadian rhythm disorders.7 Few clinical studies have been carried out regarding the anxiolytic and analgesic effects of melatonin in the perioperative period. Hence this study will be carried out to evaluate the effects of melatonin premedication on anxiety, pain, sedation score and surgeon’s satisfaction in elective phacoemulsification cataract surgery.

**Objectives**

1. To study the effect of melatonin on anxiety, pain and sedation using verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score

2. To assess the adverse effects using WHO causality assessment scale

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-27
• Last Update Posted: 2018-12-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 178

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score	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 Outcome Measures

Name	Time	Method
To assess the adverse effects using WHO causality assessment scale

Trial Locations

Locations (1)

Sri Devaraj Urs Medical College; 🇮🇳 Kolar, KARNATAKA, India

Sri Devaraj Urs Medical College

🇮🇳Kolar, KARNATAKA, India

Sarala N

Principal investigator

9845750165

n_sarala@rediffmail.com