Prevalence of cardiac autonomic neuropathy and its effect on perioperative haemodynamic parameters in diabetic patients undergoing major elective surgeries: A prospective observational study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 1.Prevalence of cardiac autonomic dysfunction in patients coming to Pre anaesthesia clinic with known or newly diagnosed diabetes mellitus
研究概览
简要总结
Cardiac autonomic neuropathy (CAN) is a serious complication amongdiabetic patients. It occurs in both type 1 and type 2 diabetes, and itsprogression results in poor prognosis and increased mortality. During itscourse, parasympathetic and sympathetic nerve fibres of the cardiovascular systemare damaged, resulting in potentially serious cardiac complications and evendeath. Poor glycaemic control and long duration of disease play an importantrole in the pathogenesis of the autonomic disturbances associated with diabetesmellitus. Anestimated 25% of diabetic patients will require surgery and associated cardiacautonomic dysfunction can be a reason for significant perioperative morbidity. Ithas been shown that diabetic patients with autonomic neuropathy are prone todevelop more cardiovascular events, including bradycardia, hypotension andcardiopulmonary arrest during induction of anaesthesia and in the perioperativeperiod, compared with non-diabetic subjects.
Autonomic nervoussystem (ANS), plays a central role in the regulation of multiple corebiological processes and its dysfunction can be a strong reason of developmentof serious postoperative morbidity which can lead to a prolonged hospital stay.
Screening of CANpreoperatively may be helpful to improve the management of diabetic surgicalpatients requiring general or regional anaesthesia. There are some studieswhich have evaluated the prevalence of cardiac autonomic dysfunction and itsanaesthetic implications, however, there is paucity of studies done in Indianpopulation and it is important to collect patient response data from severalregions, both within the country and worldwide. We are planning to conduct thisobservational study to evaluate the prevalence of cardiac autonomic dysfunctionin patients of Eastern India with diabetes mellitus who will present at ourhospital for major elective surgeries. We also plan to study the haemodynamic effectsof CAN in the perioperative period, postoperative morbidity and length ofhospital stay.
StudyDesign
Study type:Observational
Observational model: Cohort
Time perspective: Prospective
Intervention: Nointervention
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Diabetic patients scheduled for major elective surgeries.
排除标准
- •Cardiac rhythm other than sinus rhythm, Parkinson’s disease, idiopathic orthostatic hypotension, Shy-Drager syndrome, Addison’s disease and hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy, cardiomyopathy, and proven or suspected allergy for any of the medication used during induction of anaesthesia.
结局指标
主要结局
1.Prevalence of cardiac autonomic dysfunction in patients coming to Pre anaesthesia clinic with known or newly diagnosed diabetes mellitus
时间窗: 1.Baseline
次要结局
- 1.Hemodynamic response to induction of anaesthesia, laryngoscopy, intubation, extubation in patients with Cardiac autonomic dysfunction((CAN).)