Effect of different doses of oral melatonin as a premedication for attenuation of intubation response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the blood pressure (BP) and heart rate (HR) following laryngoscopy and
研究概览
简要总结
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Melatonin is a endogenous sleep regulating hormone secreted by pineal gland responsible for various physiological functions like circadian rythm, reproductive function, mood and immune function.(1) It has inhibitory action on central nervous system responsible for sedation and anxiolysis thus having role in attenuating haemodynamic response to laryngoscopy and intubation.(2)
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In our study, we compare two different doses 6mg and 9mg of oral melatonin, given as a premedication 2 hours before surgery in attenuating the haemodynamic responses to laryngoscopy and intubation.
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We hypothesize, that melatonin 9mg is more effective in attenuating haemodynamic response to laryngoscopy and intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective surgeries under general anaesthesia
- •Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) 1 and 2.
排除标准
- •Refusal to consent for study
- •Allergy to melatonin
- •Patients receiving treatment with study drug (melatonin)
- •Anticipated difficult intubation [Modified Mallampati class 3 and 4]
- •More than 2 intubation attempts or intubation time more than 15 seconds
- •Patients with uncontrolled hypertension and diabetes.
- •Patients with severe cardiac, renal or hepatic disease.
- •Pregnancy and lactation.
- •Patients on hypnotics, sedatives, anxiolytics, anti-epileptics.
结局指标
主要结局
the blood pressure (BP) and heart rate (HR) following laryngoscopy and
时间窗: Baseline, every minute for | 5 minutes, 10th and 15th minute after intubation
To evaluate the effect of oral melatonin 6mg compared with 9mg in attenuating
时间窗: Baseline, every minute for | 5 minutes, 10th and 15th minute after intubation
intubation.
时间窗: Baseline, every minute for | 5 minutes, 10th and 15th minute after intubation
次要结局
- 1.To assess the level of sedation and anxiety scores before induction of(anaesthesia.)