Dexmedetomidine Improves Oxygenation and Reduces Pulmonary Shunt in High-Risk Pediatric Patients Undergoing One-Lung Ventilation for Thoracic Surgery: A Double-Blind Randomized Controlled Trial at Damascus University Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in the PaO2
研究概览
简要总结
Children with high anesthetic risk who underwent Thoracic surgery with OLV (one lung ventilation) technique during general anesthesia were divided into two groups.
The first is an intravenous injection of dexmedetomidine at a rate of 0.4 micrograms/kg/hour as a continuous intravenous infusion. The second group, the placebo group, injected the second with a normal saline solution, an infusion that will pass through the vein, using blinded, unmarked syringes.
Three arterial blood gas (ABG) samples were taken during surgery at designated times. Circulatory PaO2 values were recorded and the Qs/Qt shunt value was calculated.
详细描述
Pediatric specific anatomy and physiology includes small ventricles with low systolic mass and poor ventricular compliance . With decreased peripheral vascular resistance (SVR) . The parasympathetic nervous system is dominant. This explains why HR is delayed compared to changes in MAP and mean blood pressure, is less affected and slower to respond. As each terminal bronchiole opens into a single alveolus and initially forms clusters of clusters, rather than fully developed alveolar clusters, these clusters continue to grow until six to eight years of age to resemble adults. The diaphragm is more horizontal, which reduces its mechanical advantage. Ventilation depends mainly on the diaphragm and the rate of its movements (breathing movements). Higher compliance of the thoracic wall is also seen with increased respiratory work.
Decreased functional residual capacity (FRC) increases pulmonary shunting and leads to atelectasis. One-lung ventilation (OLV) during general anesthesia can improve the surgical field of view, which is often used in thoracic surgery. However, OLV can lead to a mismatch in the ventilation/perfusion ratio (V/Q), leading to increased shunt and pulmonary shunt fraction (Qs/Qt) within the lungs and the occurrence of hypoxia. The ratio between the rate of flow of unoxygenated blood from the pulmonary arteries to the pulmonary veins through the shunt (Qs), and the total rate of blood flow through the lungs (Qt), i.e., the ratio between the unoxygenated blood and the total blood, is known as the pulmonary shunt fraction (Qs/Qt). The FEV1/FVC ratio represents the proportion of the total vital capacity that can be exhaled in the first second of forced expiration, whereas FEV1 indicates "Force Expiratory Volume in 1 second" and FVC indicates "Forced Vital Capacity".
Hypoventilation-induced vasoconstriction (HPV) is the body's primary compensatory mechanism against pulmonary constriction, which is to divert pulmonary perfusion blood from the nonventilated area to the ventilated area, thereby reducing pulmonary constriction and improving blood hypoxia . HPV is affected by various factors, including changes in pulmonary pressure, alkalosis, vasodilators, and inhaled anesthetic gases, which have the greatest effect. The study was designed as a two-group, controlled clinical trial using propofol, which is known to have no effect on HPV.
Dexmedetomidine is widely used as an anesthetic adjuvant. It is a highly selective alpha2 adrenergic receptor agonist that directly stimulates peripheral alpha2 receptors to induce vasoconstriction and increase blood pressure, as well as act on central alpha2 receptors to suppress sympathetic excitation, which can dilate blood vessels and lower blood pressure. Alpha adrenal blockade eliminates pulmonary arrhythmias that responded to non-adrenal but not hypoxia . Due to the complex effects of dexmedetomidine on blood circulation, it is difficult to predict its effects on intrapulmonary shunt and hypoventilation-induced vasoconstriction in patients during one-lung ventilation . The hypothesis of our study predicted that dexmedetomidine would improve oxygenation Partial Pressure of Arterial Oxygen (PaO2) and reduce pulmonary shunting during OLV in children.
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)
盲法说明
Anesthesiologists, graduate students, anesthesiologists, patients and their families will not know if a child is taking the drug or not.
Also, the person who will conduct the survey will not know either, all will be hidden.
Depending on the volume in ml, to mask the medical team from the substance of the drug...
入排标准
- 年龄范围
- 4 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with American Society of Anesthesiologists (ASA) grade III
- •FEV1/FVC values less than 80% . FEV1/FVC ratio represents the proportion of the total vital capacity that can be exhaled in the first second of forced expiration, whereas FEV1 indicates "Force Expiratory Volume in 1 second" and FVC indicates "Forced Vital Capacity".
- •Qs/Qt ratio greater than 10 .
排除标准
- •renal failure.
- •hepatic dysfunction.
- •congenital and valvular cardiac disease.
- •neurological illnesses.
- •During surgery, individuals who did not achieve complete lung isolation were excluded.
- •During surgery, individuals with poor oxygen saturation (SO2 <90%) who did not react to maneuvers and anesthetic procedures to boost saturation were removed.
- •During surgery, Participants who had a heart rate of less than 80 beats per minute, did not react to atropine, or required a dosage of inotropic drugs (dopamine) were also removed from the trial.
研究组 & 干预措施
The dexmedetomidine group
Dexmedetomidine:
An initial dose of 0.5 mcg/kg of dexmedetomidine will be given over 10 minutes, starting 10 minutes after the initiation of anesthesia infusion.
Following the initial dose, a continuous infusion of dexmedetomidine will be administered at a rate of 0.4 mcg/kg/hour.
The infusion will be stopped before skin closure.
干预措施: Dexmedetomidine (Drug)
The Placebo group (the control group):
Saline Solution (Placebo):
After the induction of anesthesia, a volume of saline solution equivalent to the volume of dexmedetomidine used in the experimental group will be administered using the same protocol.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in the PaO2
时间窗: four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.
Evaluation of Change in PaO2 During Surgery. PaO2: is Partial Pressure of Arterial Oxygen.
Change in the Qs/Qt
时间窗: four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.
Evaluation of Change in Qs/Qt During Surgery. Qs/Qt: is a Measurement of Pulmonary Shunt. Qs: Blood Flow Through the Shunt, Qt : Total Blood Flow.
次要结局
- Change in the PIP(four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.)
- Change in the MAP(four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.)
- Change in the HR(four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.)
