The Effect of Intra Operative Dexmedetomidine in Prevention of Early Postoperative Atrial Fibrillation in Patients Undergoing Thoracic Non Cardiac Surgeries: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Incidence of new onset early atrial fibrillation following thoracic non cardiac surgeries in the first 72 hours postoperative
研究概览
简要总结
The incidence of atrial fibrillation (AF) after lung resection varies between 12% and 30% after lobectomy and 23%-67% after pneumonectomy. The average time of onset of AF after lung resection is 2-3 days. AF after pulmonary resection can cause symptoms, hemodynamic instability, and stroke.Furthermore, AF following pulmonary resection may triple the mean duration stay in the intensive care unit and increase the total length of hospital stay by 2-9 days, with an increased in associated hospitalization costs.lastly, AF after lung resection has been associated with an increased risk of mortality , although the arrhythmia is more likely to be a consequence of other associated cardiopulmonary complications, rather than the main cause of death.
our study aim to assess the role of intra operative dexmedetomidine in reduction of early postoperative atrial fibrillation in patients undergoing thoracic non cardiac surgeries.
Objectives:
- To evaluate possible efficacy of intraoperative dexmedetomidine in reduction of postoperative atrial fibrillation in patients undergoing thoracic non cardiac surgeries
- To determine the incidence of new-onset atrial fibrillation after thoracic non cardiac surgeries in patients given intra operative dexmedetomidine
详细描述
This a randomized control trial is designed to include (350) patients ASA physical status II patients ranging from(18) to(70)years old scheduled for thoracic non cardiac surgeries
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group I : dexmedetomidine: (n=175) dexmedetomidine will be administered as a bolus dose, before the surgical incision with 1mcg/kg iv over 10 minutes followed by infusion rate of 0.5 μg/kg per h and stopped at the end of operation.
GroupII: normal saline placebo:(n=175) similar bolus and infusion volumes of normal saline will be administered as dexmedetomidine group
Anesthesia management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender both males and females
- •ASA Class II
- •Age 18-70 years
- •Patients undergoing thoracic non cardiac surgeries(lobectomy, pneumonectomy, and esophagectomy).
排除标准
- •A. Hypersensitivity or known allergy to dexmedetomidine. b.Patients with Sick-sinus orWolff-Parkinson-White syndromes; atrioventricular block atrial fibrillation within 30 days; a permanent pacemaker; used amiodarone or dexmedetomidine within30 days.
- •c. Patients with echocardiographic finding of an ejection fraction <30% and left atrial diameter more than 45mm and use of beta blockers or statins.
- •d. Liver and renal impairment(elevated liver enzymes (ALT, AST two to three fold), CRF ) e .Emergency operations ,video assisted thoracic surgeries and operation for spontaneous pneumothorax
研究组 & 干预措施
dexmedetomidine
dexmedetomidine will be administered as a bolus dose, before the surgical incision, followed by infusion and stopped at the end of operation
干预措施: Intra Operative Dexmedetomidine (Drug)
normal saline placebo
similar bolus and infusion volumes of normal saline will be administered
干预措施: Intra Operative Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of new onset early atrial fibrillation following thoracic non cardiac surgeries in the first 72 hours postoperative
时间窗: it will be measured in the first 72 hours postoperative
Diagnoses of atrial fibrillation in the cardiac ICU will be made by clinicians who will be masked to group allocation. Atrial fibrillation will be defined by: clinician diagnosis; documented arrhythmia lasting at least 5 min ( supraventricular tachyarrhythmia characterized by uncoordinated atrial activation .Electrocardiographic findings include the replacement of the normal consistent p waves with oscillatory or fibrillatory waves of different sizes amplitudes and timing with narrow QRS complex.The ventricular response is often rapid and between 90 and 170 beats per minute and it will be documented by 12- lead ECG.
次要结局
- The incidence of Dexmedetomidine side effects in the first 72 hours postoperative(it will be measured in the first 72 hours postoperative)
研究者
Ahmed nabih youssef
Lecturer of anesthesia
Kasr El Aini Hospital