Efficacy of Dexmedetomidine and Magnesium Sulfate in Preventing Postoperative Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of postoperative JET
研究概览
简要总结
to study the prophylactic effect of magnesium sulfate , dexmedetomidine or their combination in reduction the incidence of JETS postoperative
详细描述
Following approval from research and ethics committee, preoperative preparation, and anesthesia inductuion. the baseline heart rate (HR) and blood pressure (BP) will be recorded.
The patients will be divided into three groups according to the type of drug injected.
Group MD (dexmedetomidine Mgso4 group): include (40 ) patients and will receive dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period (Precedex ; Hospira Worldwide ,Lake Forest, IL).(20) and receiving Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release. with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day.(21) Group D (dexmedetomidine group): include (40 ) patients and will receive the same of dexmedetomidine as MD group in addition to normal saline instead of Magnesium Sulfate .
Group C (control group): include (40 ) patients and will receive normal saline instead of dexmedetomidine and MgSo4 .
after the end of the procedure, inhalational anesthetics will be stopped as well the muscle relaxant. The patient will be transferred to the ICU.
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)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: less than 5 yrs.
- •Weight: more than 5 kg .
- •Pathology :A-V canal ,VSD ,ASD undergoing corrective surgery with normal sinus rhythm, and stable hemodynamics.
排除标准
- •a history of arrhythmias within the last 6 months, current use of antiarrhythmic medication such as amiodarone, digoxin.
- •patients with pacemaker or atrioventricular (A-V) block.
- •known allergy to dexmedetomidine or magnesium sulfate.
- •patients with a history of re-do surgery.
研究组 & 干预措施
dexmedetomidine group
patients will receive the same of dexmedetomidine as MD group in addition to normal saline instead of Magnesium Sulfate .
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine Mgso4 group
patients will receive dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period (Precedex ; Hospira Worldwide ,Lake Forest, IL).(20) and receiving Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release. with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine Mgso4 group
patients will receive dexmedetomidine 0.5 µg/kg diluted in 50 mL of normal saline intravenously over 20 minutes, After induction followed by 0.5 µg/kg per hour infusion for 72 hours postoperatively or ready for extubation prior to 72 hour time period (Precedex ; Hospira Worldwide ,Lake Forest, IL).(20) and receiving Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release. with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
Incidence of postoperative JET
时间窗: for 72 hours postoperatively.
Incidence of postoperative JET for 72 hours postoperatively.
次要结局
- prognostic indices(for 72 hours postoperatively.)
- • Vasoactive - inotropic score(for 72 hours postoperatively.)
研究者
Ahmed Mohamed Mohamed Elhaddad
Lecturer of Anesthesia, ICU and Pain managment
Kasr El Aini Hospital