Comparison of two doses of melatonin for preoperative anxiolysis
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- STAI-S score at 90 minutes after drug administration in the two groups.
研究概览
简要总结
Preoperative anxiety is described as an unpleasant state of tension or uneasiness that results from a patient’s doubts or fears about the surgery and anaesthesia. It has deleterious effects on intraoperative hemodynamic stability, requirement of anaesthesia and analgesia, post-operative pain, prolonged hospital stay, health care cost and may also increase morbidity and mortality.
Melatonin (N-acetyl 5 methoxy tryptamine) is an endogenous hormone produced by the pineal gland. The primary physiological role of melatonin is to regulate the circadian rhythm. Melatonin has been studied in view of its preoperative anxiolytic and sedative effects due to its inhibitory action on central nervous system. However there is conflicting evidence on the effective and safe dose of melatonin required for preoperative anxiolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I & II
- •Patients posted for elective surgery under general anaesthesia.
排除标准
- •1.ASA physical status III and IV 2.Patients with Trait Anxiety Score STAI-T more than 45 during preanaesthetic checkup 3.Patients with known allergy to melatonin 4.Obese patients BMI more than 30 kg/m2 5.Patients already taking sedatives, anti psychotics, anxiolytics, anti epileptics 6.Pregnant and lactating mothers 7.Patient’s refusal to participate in the study.
结局指标
主要结局
STAI-S score at 90 minutes after drug administration in the two groups.
时间窗: 90 minutes
次要结局
- 1.STAI-S score, at the time of preanaesthetic check-up and just before administration of the study drug with in each group.(2.NRS-A score at 90 minutes after drug administration in the two groups.)
研究者
Dr Suneet Kant Kathuria
Dayanand Medical College and Hospital