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Completed

NCT Number: NCT06505772

Dexmedetomidine Improved Oxygenation and Reduced Shunt in One-Lung Ventilation at High-Risk Pediatric Thoracic Surgery

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine ) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL.

For example, it begins with an infusion of 4 ml over 10 minutes and then continues the infusion, depending on the weight of the child, at a rate of 1.6 ml/kg/hour.

All injections will be prepared randomly by a doctor who did not participate in the study, and then placed in unmarked infusion pumps, given to an anesthesiologist (more than 10 years experience in pediatric anesthesia) without knowledge of the infusion content. The randomization process is carried out via sealed envelope technique.

The injections in both groups will be stopped before the skin is closed. Both patients and anesthesiologists blinded the study drug (dexmedetomidine or placebo) by infusion of solution (dexmedetomidine or placebo). Depending on the size in ml, to ensure that there is no bias and blindness to the medical team about what the drug is.

Other names: Precedex

normal saline

Drug

Normal saline (NS) for intravenous infusion is supplied in pre-filled syringes of 20 ml, 50 ml, and 100 ml. To maintain blinding in this study, NS is handled identically to the study drug, dexmedetomidine. A physician not involved in the study prepares all injections, randomly assigning either NS or dexmedetomidine using a sealed envelope technique. Prepared syringes are then placed in identical, unmarked infusion pumps.

Infusion Protocol:

Anesthesiologists, blinded to the infusion contents, administer the solutions according to the protocol:

For example,Initial Bolus: 4 ml infused over 10 minutes, Maintenance Infusion: Continued at a rate of 1.6 ml/kg/hour, adjusted to the individual patient's weight.

This process ensures both patient and anesthesiologist remain blinded to the treatment arm, minimizing potential bias throughout the study.

Other names: Placebo

Primary outcomes

  1. Change in the PaO2

    Time frame: 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.

  2. Change in the Qs/Qt

    Time frame: 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.

Secondary outcomes

  1. Change in the PIP

    Time frame: 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 Peak inspiratory pressure (PIP).

  2. Change in the MAP

    Time frame: 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 Mean arterial pressure (MAP).

  3. Change in the HR

    Time frame: 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 Heart Rate (HR).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Collaborators

  • University Children's Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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