Esophageal Atresia Clinical Trial
— RCTOfficial title:
The Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt During One Lung Ventilation in Pediatric Surgery: Randomized Controlled Trial
Verified date | February 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | February 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 12 Years |
Eligibility | Inclusion Criteria: 1. As per the American Society of Anesthesiologists (ASA) classification I-I physical condition children undergoing thoracic surgery with OLV. 2. From one day old to 12 years old. 3. There is no prejudice in terms of gender. 4. 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: 1. Premature infants: due to immaturity of the lung and insufficient formation of the surfactant. 2. Cystic Fibrosis: The depressor for surfactant and lung immaturity is not permitted to perform the OLV technique 3. There is no contraindication for the administration of dexmedetomidine in children except those who show signs of allergy to the dexmedetomidine. 4. This study does not exclude practically any child who will undergo OLV. 5. 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. 6. 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. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University Children's Hospital | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University | University Children's Hospital |
Syrian Arab Republic,
Asri S, Hosseinzadeh H, Eydi M, Marahem M, Dehghani A, Soleimanpour H. Effect of Dexmedetomidine Combined with Inhalation of Isoflurane on Oxygenation Following One-Lung Ventilation in Thoracic Surgery. Anesth Pain Med. 2020 Feb 12;10(1):e95287. doi: 10.5812/aapm.95287. eCollection 2020 Feb. — View Citation
Huang SQ, Zhang J, Zhang XX, Liu L, Yu Y, Kang XH, Wu XM, Zhu SM. Can Dexmedetomidine Improve Arterial Oxygenation and Intrapulmonary Shunt during One-lung Ventilation in Adults Undergoing Thoracic Surgery? A Meta-analysis of Randomized, Placebo-controlled Trials. Chin Med J (Engl). 2017 Jul 20;130(14):1707-1714. doi: 10.4103/0366-6999.209891. — View Citation
Lin J, Li JB, Lu Z. Clinical application and effect of dexmedetomidine in combination with continuous positive airway pressure on one-lung ventilation in lung surgery of elder patients. Pak J Pharm Sci. 2018 Nov;31(6(Special)):2879-2883. — View Citation
Meng J, Lv Q, Yao J, Wang S, Yang K. Effect of Dexmedetomidine on Postoperative Lung Injury during One-Lung Ventilation in Thoracoscopic Surgery. Biomed Res Int. 2020 Oct 5;2020:4976205. doi: 10.1155/2020/4976205. eCollection 2020. — View Citation
Shen Q, Xu G, Liu J, Wang L, Zhou Y, Yu Y, Lv C, Liu X. Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages. Life Sci. 2020 Oct 15;259:118249. doi: 10.1016/j.lfs.2020.118249. Epub 2020 Aug 13. — View Citation
Sheybani S, Attar AS, Golshan S, Sheibani S, Rajabian M. Effect of propofol and isoflurane on gas exchange parameters following one-lung ventilation in thoracic surgery: a double-blinded randomized controlled clinical trial. Electron Physician. 2018 Feb 25;10(2):6346-6353. doi: 10.19082/6346. eCollection 2018 Feb. — View Citation
Wang J, Yi X, Jiang L, Dong H, Feng W, Wang S, Chu C. Protective effects of dexmedetomidine on lung in rats with one-lung ventilation. Exp Ther Med. 2019 Jan;17(1):187-192. doi: 10.3892/etm.2018.6952. Epub 2018 Nov 9. — View Citation
Xie Y, Jiang W, Zhao L, Wu Y, Xie H. Effect of dexmedetomidine on perioperative inflammation and lung protection in elderly patients undergoing radical resection of lung cancer. Int J Clin Exp Pathol. 2020 Oct 1;13(10):2544-2553. eCollection 2020. — View Citation
Xu B, Gao H, Li D, Hu C, Yang J. Nebulized dexmedetomidine improves pulmonary shunt and lung mechanics during one-lung ventilation: a randomized clinical controlled trial. PeerJ. 2020 Jun 5;8:e9247. doi: 10.7717/peerj.9247. eCollection 2020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of change in PaO2 during surgery | 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 | 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. | |
Primary | 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. | 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 |
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. | |
Secondary | Evaluation of change in CaO2 during surgery | CaO2 :arterial content of O2. CaO2 = (PaO2 × 0.0031) + (Hb × 1.36 × SaO2) | 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. | |
Secondary | Evaluation of change in CvO2 during surgery | CvO2 :venous mixed content of O2. CvO2 = (PvO2 × 0.0031) + (Hb × 1.36 × SvO2) | 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. | |
Secondary | Evaluation of change in Cc'O2 during surgery | Cc'O2 : pulmonary capillary content of O2. CcO2 = ([FiO2 × (PB -PH2o) - PaCO2/RQ] × 0.0031) + (Hb × 1.36) | 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. |
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