Effect of preoperative melatonin on anxiety and pain in patient undergoing Phacoemulsification cataract surgery
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Decrease in verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score
研究概览
简要总结
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
- To study the effect of melatonin on anxiety, pain and sedation using verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score
- To assess the adverse effects using WHO causality assessment scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Decrease in verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score
时间窗: 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.
次要结局
- To assess the adverse effects using WHO causality assessment scale