Clinical trial NCT06505772: Dexmedetomidine Improved Oxygenation and Reduced Shunt in One-Lung Ventilation at High-Risk Pediatric Thoracic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One-Lung Ventilation
Thoracic Surgery
Keywords: Hypoventilation pulmonary vasoconstriction HPV
Pulmonary shunt fraction Qs/Qt
Dexmedetomidine
partial pressure of arterial oxygen (PaO2)
Lead sponsor: Damascus University
Sponsor class: OTHER
Collaborators: name: University Children's Hospital
First posted: 2024-07-17
Enrollment: 78
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the PaO2
timeFrame: 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.
measure: Change in the Qs/Qt
timeFrame: 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.
Secondary outcomes:
measure: Change in the PIP
timeFrame: 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.
measure: Change in the MAP
timeFrame: 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.
measure: Change in the HR
timeFrame: 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.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University Children's Hospital
Study officials:
affiliation: Department of Anesthesiology Faculty of Medicine Damascus University
name: Faten Rostom, PHD
role: STUDY_CHAIR
References:
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