Effect of Melatonin Premedication in Patients Undergoing Awake Craniotomies: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient Satisfaction Score measured on a 10-point Likert Scale ( 1 being the worst experience and 10
研究概览
简要总结
| Sleep disorders in the |
| perioperative period are not uncommon. Preoperative anxiety can have adverse |
| effects on the sleep pattern of the patient undergoing surgery. Poor sleep |
| quality can lead to increased postoperative pain scores and increased length |
| of hospital stay. |
Pharmacological methods for alleviating anxiety and improving sleep quality can cause adverse effects such as drowsiness and prolonged recovery when not administered in appropriate doses. In neurosurgical patients, pharmacological methods of anxiolysis can lead to excessive drowsiness and respiratory depression and are thus generally not administered.
Oral Melatonin has various physiological effects on the body especially on the circadian rhythm. The onset of action is within 30-60 minutes and it has a duration of action of 4 to 10 hours. It induces regulation of sleep-wake rhythm in patients with sleep disturbances. It also has many potential benefits such as oncostatic effects, autonomic cardiovascular regulation, protection against neuroinflammation and antioxidant effects. As it has potent sedative and hypnotic effects, it is used as a premedication for anxiolysis in the preoperative period.
Although the role of oral melatonin premedication in patients undergoing surgery under local anaesthesia and general anaesthesia has been well established through previous research, its use as a premedicant in neurosurgical patients is less studied. Hence, this study can prove to be beneficial in establishing the role of oral melatonin premedication in neurosurgical patients undergoing awake craniotomy.
Thus, we will be studying the effect of oral melatonin premedication on patients satisfaction score, anxiety and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator 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
- •All adult patients undergoing awake craniotomy.
排除标准
- 未提供
结局指标
主要结局
Patient Satisfaction Score measured on a 10-point Likert Scale ( 1 being the worst experience and 10
时间窗: one hour after surgery
being the best )
时间窗: one hour after surgery
次要结局
- To assess the efficacy of oral melatonin premedication in decreasing preoperative anxiety in adult(patients undergoing awake craniotomy)
- To assess sleep quality on the night before surgery(morning of surgery)
- To determine the consumption of intraoperative dexmedetomidine and fentanyl
研究者
Charu Mahajan
AIIMS, New Delhi