To compare the effects of oral melatonin with oral alprazolam when used as premedication in adult patients undergoing general anaesthesia or spinal anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assess pre operative anxiety
研究概览
简要总结
Background: Preoperative anxiety is a major concern in patients undergoing any surgical procedure. Various drugs have been used to alleviate it. Benzodiazepines are among the most popular preoperative medications because they produce anxiolysis, amnesia and sedation. Melatonin is an endogenous neurohormone secreted by the pineal gland with the unique property of producing anxiolysis with no impairment of cognitive and psychomotor function. However there have been few studies comparing oral alprazolam and oral melatonin.
Aims and Objectives: To compare the effects of oral melatonin with oral alprazolam on preoperative anxiety, sedation, and orientation when given as premedication.
To study the side effects of alprazolam and melatonin, if any.
Materials and Methods: This prospective, randomized controlled study will be conducted on 80 patients, 40 in each group undergoing elective surgeries under general anaesthesia or spinal anaesthesia. Group A will be for patients receiving Tablet Alprazolam and Group B will be for patients receiving Tablet Melatonin. On Day 0, i.e. the day of the pre-anaesthetic checkup, the patients’ haemodynamic parameters as well as Visual Analogue Scale for anxiety (VAS-A) score, Ramsay sedation score (RSS) and Orientation Score will be assessed. On Day 1, i.e. the day of surgery, after the administration of drug one hour prior to the surgery, the same parameters will be assessed inside the operation theatre before starting anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •All consenting adults who are: 1.Aged between 18-60 years.
- •2.ASA I and II patients planned for elective surgeries under general anaesthesia or spinal anaesthesia anticipated to last more than one hour.
- •3.Patients admitted into the hospital at least a day prior to the planned procedure.
排除标准
- •1.Age below 18 years or above 60 years 2.All emergency cases.
- •3.History of allergy to either of the study drugs i.e. Tab.
- •Alprazolam and Tab.
- •4.History of drug addiction.
- •5.Patients with psychiatric disorders on medication with benzodiazepenes.
- •6.Patients who are chronic alcoholics or who have consumed alcohol in the 24 hours prior to planned procedure.
- •7.Patients with a BMI of more than 30.
结局指标
主要结局
Assess pre operative anxiety
时间窗: At the time of pre-a aesthetic check up | One hour prior to shifting to ot
次要结局
- To check for adverse effects of Tab. Alprazolam and Tab. Melatonin(1. During pre anesthetic check up)