Effects of melatonin premedication on the hemodynamic responses and perfusion index during laryngoscopy and endotracheal intubation-A Randomized control study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The Primary outcome for this study is likely the change in the hemodynamic responce,which includes measurment such as blood pressure and heart rate,during laryngoscopy and endotracheal intubation following melatonin premedication..
研究概览
简要总结
Several techniques have been proposed to prevent or attenuate the hemodynamic responses following laryngoscopy and intubation , preoperative melatonin has a significant analgesic and anxiolytic effect for patients undergoing surgery. Endotracheal intubation is one of the most invasive stimuli in anaesthesia particularly during induction and after tracheal intubation. It is usually well tolerated by normotensive patients ,but even short-lasting stimulation has been associated with increased morbidity and mortality in patients with recent myocardial infarction, hypertension, pre-eclampsia and cerebrovascular pathology such as tumors, aneurysms or increased intracranial pressure. Stress response increases both SBP and DBP measurements increase by 36-40% in contrast to control levels .Heart rate levels increase more than 20% with tracheal intubation in contrast to laryngoscopy. The pressor (stress) response reaches a peak 1-2 min after laryngoscopy and tracheal intubation, and usually subsides within 5-6 min ,although tachycardia may persist for 10min .Studies in humans indicate that 1mg 0f melatonin increases arterial pressure and the plasma levels of noradrenaline during standing .
Melatonin (N-acetyl -5-methoxytryptamine) is an endogenous sleep-regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep onset and improves the quality of sleep .it different from benzodiazepines and their derivatives in that it produces natural sleep pattern and does not lead to impairment of cognitive functions .various researchers have used this drug in different dose patterns as premedication in both adult as well children. It has been mainly studied in view of preoperative anxiolysis, sedation in intensive care unit, preoperative cognitive and psychomotor functions.
The current study aimed at assessing the usefulness of melatonin in attenuating the pressor response to direct laryngoscopy and tracheal intubation.
and preop anxiety and post op sedation using different doses of melatonin.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to the American Society of Anaesthesiologists physical status grade 1 & 2 2) Surgery requiring general anaesthesia for duration for longer than 30 min.
- •Patients who are willing to give inform consent.
排除标准
- •Patients having uncontrolled diabetes,hypertension,psychiatric illness,intake of antipsychotics,sedatives,anxiolytics and antiepileptics drugs;sleep disorders.
- •Patients with obesity 3)Patients having drug allergy.
- •Patient with anticipated difficult intubation 5)Patients requiring more than one attempt or more than 20s for laryngoscopy 6)Patient refusal.
结局指标
主要结局
The Primary outcome for this study is likely the change in the hemodynamic responce,which includes measurment such as blood pressure and heart rate,during laryngoscopy and endotracheal intubation following melatonin premedication..
时间窗: Hemodynamic parameters taken at prior medication,baseline ,just before intubation after intubation,5min,10min,15min
次要结局
- 1.Incidence of adverse effects related to melatonin premedication.(2.level of sedation or anxiety in patients before the procedure.)
研究者
DR Manjunath Pirappa Dali
Bangalore Medical College And Research Institute Bengaluru