跳至主要内容
临床试验/NCT05860010
NCT05860010尚未招募不适用

Comparing the Hemodynamic Effects of Epinephrine Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Caudal Anaesthesia Assessed by Cardiometry: a Randomized, Double-blind, Controlled Study

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年6月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
39
试验地点
2
主要终点
The percentage change in cardiac output after caudal injection

研究概览

简要总结

Electrical cardiometry (EC) is a non-invasive method of estimating cardiac parameters by measuring changes in thoracic bioimpedance during the cardiac cycle. The ICON (Cardiotronic Osypka Medical, San Diego, California) monitor uses four electrocardiogram electrodes and estimates the maximum rate of impedance change to peak aortic blood acceleration. An impedance change occurs between diastole and systole as red blood cell orientation is altered from random during diastole to align during systole. This device is validated against Fick cardiac output and transthoracic echocardiography in infants and children, as well as thermodilution in adults with R values of 0.9. This device is approved by the Food and Drug Administration (FDA) for use in pediatrics. Hypotension is expected to occur after epidural anesthesia (EA) due to the dilatation of venous vessels by sympathetic blockade with a subsequent decrease in venous return and cardiac output (CO). Also, the association of general anesthesia (GA) to EA can lead to more decrease in CO. The addition of epinephrine to local anesthetics (LA) could worsen hypotension through the systemic absorption of epinephrine that leads to a vasodilator β effect. Yet, CO may be enhanced by this β-adrenergic stimulation. However, it is well known that caudal epidural anesthesia has few or no hemodynamic changes in children less than 8 yr old. This could be attributed to the immaturity of their sympathetic system and smaller lower-limbs blood volume compared to adults. Caudal anesthesia is highly effective in abdominal, urinary tract, and lower extremity surgeries in children for intra- and postoperative analgesia. The addition of dexmedetomidine to local anesthetics in caudal anesthesia is a frequent practice. Dexmedetomidine, a highly selective alpha-2 adrenoreceptor agonist, is used as an intravenous sedative and analgesic drug. It has an a2/a1 selectivity ratio of 1600: 1 and is eight times more potent than clonidine. Intrathecal and epidural dexmedetomidine have been reported to produce analgesic properties, prolonging the duration of local anesthetics without causing nerve damage in pediatric patients.

Although basal heart rate is greater than in adults, activation of the parasympathetic nervous system, anesthetic overdose, or hypoxia can quickly trigger bradycardia and profound reductions in cardiac output. The sympathetic nervous system and baroreceptor reflexes are not fully mature and the infant cardiovascular system displays a blunted response to exogenous catecholamines. That's why it is very essential to determine the hemodynamic effects of any drug used as an adjuvant to local anesthetics for caudal block and to explore whether it reduces the child cardiac output or not.

As invasive cardiac monitors are rarely indicated in pediatric patients, and little is known about the impact of caudally administered dexmedetomidine on cardiac function, so we aimed to investigate its effect on hemodynamic functions measured by EC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I and II, pediatric patients aged between 6 months and 8 years, of male or female gender, and undergoing elective infraumbilical (i.e. lower abdominal or genitourinary surgeries) will be included.

排除标准

  • Parent or guardian refusal
  • Patients < 6 months and > 8 years old
  • Emergency cases
  • Surgery lasting > 60 min
  • Patients with known congenital heart disease.
  • Patients with history or evidence of infection at the back.
  • Congenital abnormalities of lower spine or meninges e.g. spina bifida
  • Patients with blood clotting disorders or on anticoagulation therapy.
  • Patients with known allergy to systemic or local anesthetics

研究组 & 干预措施

control

Placebo Comparator

Bupivacaine will be administered in the caudal space

干预措施: Bupivacaine (Drug)

dexmedetomidine

Active Comparator

caudal with dexmedetomidine

干预措施: Dexmedetomidine (Drug)

dexmedetomidine

Active Comparator

caudal with dexmedetomidine

干预措施: Bupivacaine (Drug)

epinephrine

Active Comparator

caudal with epinephrine

干预措施: Epinephrine injection (Drug)

epinephrine

Active Comparator

caudal with epinephrine

干预措施: Bupivacaine (Drug)

结局指标

主要结局

The percentage change in cardiac output after caudal injection

时间窗: 15 minutes after caudal injection

the change of cardiac output before and after caudal injection in percent

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Abougabal

consultant of anesthesia

Kasr El Aini Hospital

研究点 (2)

Loading locations...

相似试验