One Lung Ventilation OLVRCTNCT04932746
The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery.
A study testing Dexmedetomidine in people with One Lung Ventilation OLV and Esophageal Atresia, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- One Lung Ventilation OLV, Esophageal Atresia, Hydrocystoma
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSyria
- Study dates
- 1 Mar 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt During One Lung Ventilation in Pediatric Surgery: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- One Lung Ventilation OLV, Esophageal Atresia, Hydrocystoma, Pneumonectomy, Pleura; Abscess
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Dexmedetomidine, One lung ventilation OLV, Hypoxic pulmonary vasoconstriction HPV, Pulmonary shunt fraction Qs / Qt
- Medical subject headings
- Esophageal Atresia, Hidrocystoma, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
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.
PlaceboDrug
Also called Saline
The same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol
| Study group | Role | What they receive |
|---|---|---|
| The dexmedetomidine group: | Experimental | 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. Receives: Drug: Dexmedetomidine |
| The Placebo group (the control group): | Experimental | After the same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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 outcomes (3)
Evaluation of change in CaO2 during surgery
CaO2 :arterial content of O2. CaO2 = (PaO2 × 0.0031) + (Hb × 1.36 × SaO2)
Measured: 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.
Evaluation of change in CvO2 during surgery
CvO2 :venous mixed content of O2. CvO2 = (PvO2 × 0.0031) + (Hb × 1.36 × SvO2)
Measured: 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.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Mar 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for One Lung Ventilation OLVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Faten Rostom, PHD, Study chair, Head of the Department of Anesthesiology Al-Assad University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932746
- Sponsor's protocol ID
- UDMS-Anesth-01-2021
- Acronym
- RCT
- Status last verified
- Feb 2023
- First submitted
- 23 May 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32309196Huang 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.
PubMed 28685722Lin 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.
PubMed 30630803Meng 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.
PubMed 33083468Shen 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.
PubMed 32798558Sheybani 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.
PubMed 29629058Wang 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.
PubMed 30651781Xie 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.
PubMed 33165407Xu 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.
PubMed 32547872
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt During One Lung Ventilation in Pediatric Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04932746
- Acronym / sponsor ID
- RCT / UDMS-Anesth-01-2021
- Conditions
- One Lung Ventilation OLV, Esophageal Atresia, Hydrocystoma, Pneumonectomy, Pleura; Abscess
- Keywords
- Dexmedetomidine, One lung ventilation OLV, Hypoxic pulmonary vasoconstriction HPV, Pulmonary shunt fraction Qs / Qt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- University Children's Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The dexmedetomidine group: | Experimental | Drug: DexmedetomidineAn 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. |
| The Placebo group (the control group): | Experimental | Drug: PlaceboAfter the same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol. |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexInfusion 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. | Drug | The dexmedetomidine group: |
| PlaceboAlso: SalineThe same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol | Drug | The Placebo group (the control group): |
Primary outcome
Evaluation of change in PaO2 during surgery
Time frame: 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.
Time frame: 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: 1. Measurement of arterial blood gases ABG from arteries (radial or aorta) and the values it provides: 1. PaO2: partial pressure of arterial oxygen 2. SaO2: the degree of oxygen saturation of arterial hemoglobin 3. Hb: hemoglobin 2. Measurement of ABG from the pulmonary artery or from the right atrium via central catheter 1. PvO2: partial pressure of venous oxygen 2. SvO2: the degree of oxygen saturation of venous hemoglobin 3. Hb: hemoglobin 3. The following values 1. PB = (759 ~ 760) atmospheric pressure 2. PH2O = 47 water vapor pressure at a body temperature of 37 3. RQ = 0.8: RER = respiratory exchange rate when anesthetized 4. FiO2 The Fraction of Inspired Oxygen
3 secondary outcomes
Evaluation of change in CaO2 during surgery
Time frame: 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.
Evaluation of change in CvO2 during surgery
Time frame: 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.
Evaluation of change in Cc'O2 during surgery
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Background: PubMed 32309196Asri 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.
- Background: PubMed 28685722Huang 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.
- Background: PubMed 30630803Lin 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.
- Background: PubMed 33083468Meng 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.
- Background: PubMed 32798558Shen 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.
- Background: PubMed 29629058Sheybani 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.
- Background: PubMed 30651781Wang 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.
- Background: PubMed 33165407Xie 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.
- Background: PubMed 32547872Xu 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.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faten Rostom, PHD study chair
Head of the Department of Anesthesiology Al-Assad University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with One Lung Ventilation OLV and Esophageal Atresia, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of change in PaO2 during surgery (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932746, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.