Effects Of Adjuvants (Dexamethasone and Dexmedetomidine) to Caudal Anesthesia on Cardiac Output and Hemodynamics Measured By Electrical Cardiometry In Children: A Randomized Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Change in Cardiac output
研究概览
简要总结
Caudal epidural anesthesia is one of the most common regional techniques used for post-operative pain management in pediatric patients. In this study we are going to compare the effects of caudal bupivacaine , caudal Dexamethasone with bubivacaine and Dexmedetomidine with bupivacaine on the systemic vascular resistance and the cardiac output, in pediatric patients undergoing lower abdominal surgeries, by using the electrical cardiometry (EC).
详细描述
Participants will be randomly allocated by a computer-generated table into one of the 3 study groups; the randomization sequence was concealed in sealed envelopes. The three study groups were as follows:
Group A: Caudal Dexmedetomidine block group (DEXM) (n= 16) will receive caudal block using the bupivacaine 0.25% and Dexmedetomidine 1 μg/kg with the conventional general anesthesia,
Group B: caudal Dexamethasone Block group (DEXA) (n =16) will receive caudal block using the bupivacaine 0.25% and Dexamethasone 0.1 mg/kg with the conventional general anesthesia,
Group C: caudal with bubivacaine (CONTROL) group (n = 16) will receive caudal block using the bupivacaine 0.25% and general anesthesia.
After induction of general anesthesia, the electrodes of the electrical cardiometry will be applied on the child neck and chest in the supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume will be taken using the electrical cardiometry. Baseline blood pressure and heart rate will be also recorded.Then, another measurement for the systemic cardiac output, vascular resistance, stroke volume heart rate and blood pressure will be taken at 5minutes, 10 minutes, 20 minutes and 30 minutes after caudal block. The measurements will be stored and analyzed off-line.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients 1 - 7 years.
- •Both genders (male & female).
- •ASA I & ASA II patients.
- •Children scheduled for lower abdominal elective surgeries including genitourinary and perineal regions surgeries.
排除标准
- •Parents' refusal of regional block.
- •Patients requiring emergency procedures.
- •Bleeding disorders.
- •Skin lesions or wounds at site of proposed needle insertion.
- •Cutaneous anomalies (angioma, hair tuft, nevus or a dimple) near the puncture point requiring radiological examination (ultrasound, CT or MRI).
- •Progressive neurological disorders.
- •Patients with congenital heart disease.
- •Patients with Allergies to used drugs
- •Surgeries with large fluid shift or massive blood loss.
研究组 & 干预措施
Caudal block with dexmedetomedine
Caudal Dexmedetomidine block group (DEXM) (n= 16) will receive caudal block using the bupivacaine 0.25% and Dexmedetomidine 1 μg/kg with the conventional general anesthesia,
干预措施: Caudal block with dexmedetomedine (Drug)
Caudal block with dexamethasone
caudal Dexamethasone Block group (DEXA) (n =16) will receive caudal block using the bupivacaine 0.25% and Dexamethasone 0.1 mg/kg with the conventional general anesthesia,
干预措施: Caudal dexamethasone (Drug)
Control (caudal block with bupivacaine)
caudal with bubivacaine (CONTROL) group (n = 16) will receive caudal block using the bupivacaine 0.25% and general anesthesia.
干预措施: Control (bupivacaine) (Drug)
结局指标
主要结局
Change in Cardiac output
时间窗: up to 30 minutes
Cardiac output at 5 minutes, 10 minutes, 20 minutes and 30 minutes after caudal block,the cardiac output is measured with L/minute
次要结局
未报告次要终点
研究者
Doaa Fawzy Abd El Fattah Hassan
Assistant lecturer of anesthesia, surgical ICU and pain management - Cairo University
Kasr El Aini Hospital