Effect of preoperative oral melatonin on perioperative anxiety and hemodynamic response to intubation: A double-blind randomized controlled trial in patients undergoing surgery under general anesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hamilton anxiety score
研究概览
简要总结
Laryngoscopy and endotracheal intubation are potent noxious stimuli that can elicit significant sympathetic responses, resulting in undesirable cardiovascular, respiratory, and physiological alterations. These perioperative stress responses are further compounded by preoperative anxiety, which is known to adversely affect patient outcomes. The selection of appropriate premedication and anesthetic strategies plays a critical role in mitigating these effects.
Melatonin, a naturally occurring hormone, has demonstrated anxiolytic, sedative, and analgesic properties, with the added advantage of minimal impact on hemodynamic stability. Given its favorable pharmacological profile, melatonin may serve as an effective premedicant for attenuating anxiety and blunting the hemodynamic response to laryngoscopy and intubation.
Therefore, this study aims to evaluate the efficacy of preoperative oral melatonin in reducing perioperative anxiety and suppressing hemodynamic responses during laryngoscopy and intubation in patients undergoing surgery under general anesthesia.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing to give written consent ASA 1/2 patients who will undergo surgical procedures under general anaesthesia No use of anxiolytic narcotic 24 hours before surgery Non pregnant females.
排除标准
- •Patient with reduced level of consciousness Known history of allergy to drugs Advanced hepatic renal and respiratory diseases Patients with anticipated difficult Airway Patients with uncontrolled hypertension and diabetes mellitus.
结局指标
主要结局
Hamilton anxiety score
时间窗: Pre-operative and post-operative at 2 hours and 6 hours post-op
次要结局
- Hemodymanics, VAS score, Ramsay sedation score, side effects(Preoperative, intra-operative & post-operatively at 2 hours & 6 hours)
研究者
Supriya
Bangalore medical college and research institute