A Comparative study between oral melatonin and oral alprazolam as premedicants in patients undergoing surgeries under general anaesthesia: A Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To see the reduction in perioperative anxiety with the use of melatonin vs alprazolam in patient undergoing elective surgery under general anaesthesia.
研究概览
简要总结
Preoperative anxiety is a prevalent issue among patients awaiting elective surgery often driven by
fear of the procedure, anesthesia or hospitalisation. This psychological state can trigger
sympathetic nervous system responses such as elevated heart rate, blood pressure, and perspiration,
which may complicate anesthesia management by increasing anaesthetic requirements and causing
hemodynamic instability. Traditionally, benzodiazepines like alprazolam have been widely used
for their anxiolytic and sedative properties. Alprazolam, a triazolebenzodiazepine, is considered
more anxioselective than others in its class; however, it is associated with drawbacks like cognitive
impairment, restlessness, and dependency risk. In contrast, melatonin a hormone naturally
secreted by the pineal gland has shown promise as a safer alternative. Melatonin induces sedation
and anxiolysis without impairing cognitive or psychomotor function and is known for its
antioxidant, anti-inflammatory, and chronobiotic effects. The current study aims to compare the
effectiveness of oral melatonin (6 mg) and oral alprazolam (0.5 mg) in reducing preoperative
anxiety and to assess their impact on sedation, orientation, cognitive function, and patient
satisfaction. This randomized, double-blind clinical trial will be conducted in the Department of
Anaesthesiology at RIMS, Imphal, enrolling 96 adult patients aged 18-60 years, categorised as
ASA grade I or I. Participants will be randomly assigned to one of two groups-melatonin or
alprazolam,-and administered their respective medications 120 minutes before anesthesia.
Preoperative anxiety, sedation, and cognitive functions will be assessed using validated tools like
the Visual Analogue Scale, Ramsay Sedation Score, Orientation Score, and Digit Symbol
Substitution Test. Standardised anesthesia will be provided across all groups. Data will be
statistically analyzed using SPSS, with significance set at p less than 0.05. This study seeks to address the
limited data comparing these two agents and aims to provide evidence based guidance on the use
of melatonin as a potential alternative to benzodiazepines in preoperative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •Patients of either sex with ASA physical grade 1 and 2 of age group 18 to 60years.
排除标准
- •Patient with Allergy to study drugs Pregnant women Patient with mental illness Patient on steroids and antipsychotic drugs Patient unable to read or write.
结局指标
主要结局
To see the reduction in perioperative anxiety with the use of melatonin vs alprazolam in patient undergoing elective surgery under general anaesthesia.
时间窗: The study drug will be given 120 minutes before the patient is taken inside the operation theatre at the pre anaesthetic check up room. | 1st assessment will be done 120 minutes before the drug is given and 2nd assessment will be done 120 minutes after the drug has been given.
次要结局
- To assess the hemodynamic parameters and evaluate the effects of melatonin and alprazolam on sedation cognition psychomotor function and patients satisfaction in the perioperative period.(60 minutes after administration of premedication and before induction of Aneasthesia.)
研究者
Kunzang lepcha
Regional Institute of medical sciences Imphal