Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hemodynamic Parameters - Cardiac Output
研究概览
简要总结
The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population .
The main questions it aims to answer are:
Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery?
Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ?
Does dexmedetomidine exert stress reducing properties in this population?
Participants will:
Either be administered Dexmedetomidine in a loading/maintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.
详细描述
Atrial Septal Defect (ASD) is one of the most common congenital anomalies in pediatric and even in adult population, it is associated with a left-to-right shunt resulting in right ventricular (RV) volume overload and increase in pulmonary blood flow eventually culmination in right ventricular heart failure (RVHF) and pulmonary hypertension.
Percutaneous closure of ASD was devised nearly a half century ago, and now constitutes a viable alternative to the standard approach of surgical closure. Anesthesia for pediatric patients undergoing percutaneous closure involves a spectrum from sedation to general anesthesia using a variety of drugs according to institutional protocol.
Stress response represents the sum of metabolic nd hormonal perturbations initiated by the hypothalamo-pituitary-adrenal axis in response to the surgical stimulus.
Dexmedetomidine is an α2-adrenoreceptor agonist possessing stress ameliorating effects exerted on the central sympathetic outflow. It can be used either alone in sedation or as supplementation to general anesthesia. It possesses a remarkable hemodynamic stability profile and due to its prolonged duration of action, it plays a significant role in reducing emergence delirium.
This study aims at evaluating utility of dexmedetomidine as a supplementary agent to general anesthesia on hemodynamic stability / cardiac output, reduction of pediatric emergence delirium and stress hormone levels in pediatric patients undergoing transcatheter closure of ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum
排除标准
- •ASA IV, V
- •Neurological problems (cerebral palsy, mental retardation, etc.,)
- •Children with chromosomal abnormalities or other multiple congenital anomalies or other complex cardiac anomalies
- •Hepatic or renal insufficiency
- •History of allergy to the drugs used
- •Previous Cardiac Surgery
研究组 & 干预措施
Group GD
Anesthesia induction and maintenance with sevoflurane inhalational anesthesia in addition dexmedetomidine diluted in normal saline (NS) to a concentration of 4ug/ml (in a 50 ml syringe) bolus dose will be administered through the IV catheter at 1 ug/kg over 10 minutes, followed by an infusion rate of dexmedetomidine 0.5ug/kg/hr with use of a syringe pump.
干预措施: Dexmedetomidine (Drug)
Group GS
Anaesthesia induction and maintenance with sevoflurane inhalational anaesthesia in addition a 50 ml syringe admisinstered at the same initial rate and maintenance rate as would a vloume-matched dexmedetomidine syringe. Syringes will be prepared by an independent party.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
Hemodynamic Parameters - Cardiac Output
时间窗: Baseline , Perioperatively
Cardiac Output/Cardiac index assessed via VTI derived Stroke volume
Hemodynamic Parameters - Heart Rate
时间窗: Baseline , Perioperatively
Hemodynamic Parameters - Mean Arterial Blood Pressure
时间窗: Baseline , Perioperatively
次要结局
- Quality of Recovery(Perioperatively)
- G. Recovery Time(Perioperatively)
- Time to extubation(Perioperatively)
- Stress Hormones(Baseline , Perioperatively)
- Side Effects(Perioperatively)
研究者
Mohamed Ahmed Adel Okasha
Assistant Lecturer
Alexandria University