RCT: The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery.

Sponsor

Damascus University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04932746

Collaborator

University Children's Hospital (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The children who will undergo OLV (one lung ventilation) through general anesthesia will be divided into two groups:

The first will be intravenous infusion of dexmedetomidine at 0.4 mcg / kg / hour, and the second will be intravenous infusion of normal saline.

We will take three samples of arterial blood gas (ABG) during the surgery at certain times. We record the hemodynamic values, PaO2, and calculate the value of the shunt Qs / Qt.

Condition or Disease	Intervention/Treatment	Phase
One Lung Ventilation OLV Esophageal Atresia Hydrocystoma Pneumonectomy Pleura; Abscess	Drug: Dexmedetomidine Drug: Placebo	N/A

Detailed Description

Lung isolation or one lung ventilation OLV means the mechanical separation of the lungs with independent ventilation of one lung from the other, in order to provide a suitable space for the work of the surgeon, and to protect a healthy lung from bleeding or edema caused by lung damage. OLV can lead to a mismatch in the ventilation / perfusion (V / Q) ratio resulting in increased intrapulmonary shunt as well as hypoxia.

Hypoxic pulmonary vasoconstriction HPV is the most important preventive mechanism against hypoxemia, as blood flow moves from the unventilated lung to the ventilated lung to maintain an adequate arterial oxygen transport rate, HPV is a defense mechanism against hypoxia as it reduces pulmonary shunt. So that there is less oxygen drop than expected. HPV reaches its maximum effect in 15 minutes, resulting in decreased pulmonary shunt, homogenization of ventilation / perfusion ratio, and improved oxygen delivery. HPV is affected by various factors: changes in pulmonary pressure, alkalosis, vasodilators, anesthetic agents etc. Among these factors, anesthetic inhaled gases have the greatest effect on HPV.

Pulmonary shunt: It is the sum of the physiological shunt (poorly ventilated air sacs) and the anatomical shunt and the pulmonary shunt fraction (Qs/Qt) is calculated from the equation Qs/Qt = (CcO2 - CaO2)/(CcO2 - CvO2) Qs: blood flow through the shunt, Qt : total blood flow, Cc'O2 : pulmonary capillary content of O2, CaO2 : arterial content of O2, CvO2 : venous mixed content of O2 100% O2 test: often performed in a cardiac catheterization lab, operating room, or ICU, the patient breathes 100% O2 until nitrogen is washed out from their lungs (20 minutes). The oxygen concentration even in poorly ventilated units will approach 100%. This means that the partial pressure and blood saturation are equal in the poorly ventilated and well-ventilated alveolar units, thus the physiological pulmonary shunt is canceled and the anatomical pulmonary shunt remains After lung isolation and OLV application, we perform anesthesia maneuvers on the ventilator and adjust the applied ventilators in order to maintain adequate oxygenation of the patient: increased PEEP, increased FLOW, increased tidal volume Vt, increased Pmax, increased FiO2, thus eliminating the physiological pulmonary shunt and the anatomical pulmonary shunt remains, in total we apply 100% O2 testing.

Dexmedetomidine is a selective agonist for α2 receptors whose affinity for α2 receptors is eight times more than clonidine. At a dose of 0.3 mg / kg it activates protein G and inhibits norepinephrine secretion. When given in larger doses or infusion it stimulates the peripheral α2 receptors; It reduces the levels of norepinephrine in the plasma by more than 90%, thus reducing the cells' metabolism and their need for oxygen.Sympathetic blocker: Reduces heart rate, blood pressure and oxygen consumption of the heart muscle. Studies have shown that alpha-adrenergic blockade abolished pulmonary vasoconstriction that responds to norepinephrine but not to hypoxia. That is, it does not affect the blood supply and HPV of the unventilated lung, widens the blood vessels of the ventilated lung, and reduces the anesthetic requirements (affecting HPV); Reduces 30% of the need for propofol; It reduces desflurane concentration and its subsequent inhibitory effect on HPV. It may also lead to transient increases in pulmonary artery pressure related to its direct effects on vascular smooth muscle through alpha-adrenergic receptors.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Triple masking: 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...

Primary Purpose:

Treatment

Official Title:

The Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt During One Lung Ventilation in Pediatric Surgery: Randomized Controlled Trial

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The dexmedetomidine group: An initial dose of 1 mcg / kg 1 dexmedetomidine will be given 10 minutes after the start of anesthesia infusion within 10 minutes, after which the dexmedetomidine infusion is maintained at a dose of 0.4 mcg / kg / hour. The injection will be stopped before the skin is closed.	Drug: Dexmedetomidine Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine or placebo) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL. It begins with infusion of 4 ml within 10 minutes and then continues infusion, depending on the child's weight, at 1.6 ml / kg / h. 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
Experimental: The Placebo group (the control group): After the same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol.	Drug: Placebo The same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol Other Names: Saline

Arm

Intervention/Treatment

Experimental: The dexmedetomidine group:

An initial dose of 1 mcg / kg 1 dexmedetomidine will be given 10 minutes after the start of anesthesia infusion within 10 minutes, after which the dexmedetomidine infusion is maintained at a dose of 0.4 mcg / kg / hour. The injection will be stopped before the skin is closed.

Drug: Dexmedetomidine

Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine or placebo) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL. It begins with infusion of 4 ml within 10 minutes and then continues infusion, depending on the child's weight, at 1.6 ml / kg / h. 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

Experimental: The Placebo group (the control group):

After the same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol.

Drug: Placebo

The same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Evaluation of change in PaO2 during surgery [Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.]
PaO2 : The partial pressure of oxygen The partial pressure of oxygen, also known as PaO2, is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood
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. [Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.]
It describes the percentage of blood that reaches the left side of the heart without picking up oxygen. The pulmonary shunt fraction (Qs/Qt) is calculated from the equation Qs/Qt = (CcO2 - CaO2)/(CcO2 - CvO2) Parameters we need to the equation: Measurement of arterial blood gases ABG from arteries (radial or aorta) and the values it provides: PaO2: partial pressure of arterial oxygen SaO2: the degree of oxygen saturation of arterial hemoglobin Hb: hemoglobin Measurement of ABG from the pulmonary artery or from the right atrium via central catheter PvO2: partial pressure of venous oxygen SvO2: the degree of oxygen saturation of venous hemoglobin Hb: hemoglobin The following values PB = (759 ~ 760) atmospheric pressure PH2O = 47 water vapor pressure at a body temperature of 37 RQ = 0.8: RER = respiratory exchange rate when anesthetized FiO2 The Fraction of Inspired Oxygen

Secondary Outcome Measures

Evaluation of change in CaO2 during surgery [Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.]
CaO2 :arterial content of O2. CaO2 = (PaO2 × 0.0031) + (Hb × 1.36 × SaO2)
Evaluation of change in CvO2 during surgery [Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.]
CvO2 :venous mixed content of O2. CvO2 = (PvO2 × 0.0031) + (Hb × 1.36 × SvO2)
Evaluation of change in Cc'O2 during surgery [Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.]
Cc'O2 : pulmonary capillary content of O2. CcO2 = ([FiO2 × (PB -PH2o) - PaCO2/RQ] × 0.0031) + (Hb × 1.36)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

As per the American Society of Anesthesiologists (ASA) classification I-I physical condition children undergoing thoracic surgery with OLV.
From one day old to 12 years old.
There is no prejudice in terms of gender.
This study practically does not exclude any child who will undergo OLV even in the presence of cardiac, renal or hepatic diseases.

Or even in the presence of cardiac stimulants and supports (dopamine or dopamine), provided that the general condition is stable, which allows surgery and OLV.

Exclusion Criteria:

Premature infants: due to immaturity of the lung and insufficient formation of the surfactant.
Cystic Fibrosis: The depressor for surfactant and lung immaturity is not permitted to perform the OLV technique
There is no contraindication for the administration of dexmedetomidine in children except those who show signs of allergy to the dexmedetomidine.
This study does not exclude practically any child who will undergo OLV.
During operating surgery: The child is excluded from the study if hypoxia occurs (SpO2 <90%) and did not respond to maneuvers and anesthetic techniques (Increase PEEP Increase the FLOW, Tidal volume, increase Vt, Pmax increased pressure, FiO2 increased) Then the lungs are periodically ventilated with positive pressure, and the OLV technique is switched off and the child is excluded from the pilot study.
During operating surgery: If there is a drop-in heart rate less than 60 beats / minute and it does not respond to atropine or an increased dose of Cardiac tonics (dopamine).

At this time the infusion of dexmedetomidine is stopped, it is assumed that there is no very slow pulse, and if it does, it is likely that the primary cardiac lesion is the cause.