One-Lung VentilationNCT06505772
Dexmedetomidine Improved Oxygenation and Reduced Shunt in One-Lung Ventilation at High-Risk Pediatric Thoracic Surgery
A study testing Dexmedetomidine and Normal saline in people with One-Lung Ventilation and Thoracic Surgery, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- One-Lung Ventilation, Thoracic Surgery
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSyria
- Study dates
- 1 Mar 2023to 1 Jul 2024
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- One-Lung Ventilation, Thoracic Surgery
- Being tested
- Dexmedetomidine, Normal saline
- Keywords
- Hypoventilation pulmonary vasoconstriction HPV, Pulmonary shunt fraction Qs/Qt, Dexmedetomidine, partial pressure of arterial oxygen (PaO2)
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 ) 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.
Normal salineDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| The dexmedetomidine group | Experimental | Dexmedetomidine:
An initial dose of 0.5 mcg/kg of dexmedetomidine will be given over 10 minutes, starting 10 minutes after the initiation of anesthesia infusion.
Following the initial dose, a continuous infusion of dexmedetomidine will be administered at a rate of 0.4 mcg/kg/hour.
The infusion will be stopped before skin closure. Receives: Drug: Dexmedetomidine |
| The Placebo group (the control group): | Placebo comparator | Saline Solution (Placebo):
After the induction of anesthesia, a volume of saline solution equivalent to the volume of dexmedetomidine used in the experimental group will be administered using the same protocol. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the PaO2
Evaluation of Change in PaO2 During Surgery. PaO2: is Partial Pressure of Arterial Oxygen.
Measured: 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.
Change in the Qs/Qt
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.
Measured: 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 (3)
Change in the PIP
Evaluation of Change in Peak inspiratory pressure (PIP).
Measured: 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.
Change in the MAP
Evaluation of Change in Mean arterial pressure (MAP).
Measured: 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.
Change in the HR
Evaluation of Change in Heart Rate (HR).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
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 VentilationStudies 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
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 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, Department of Anesthesiology Faculty of Medicine Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505772
- Sponsor's protocol ID
- UDMS-Anesth-02-2024
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Licker M, Hagerman A, Jeleff A, Schorer R, Ellenberger C. The hypoxic pulmonary vasoconstriction: From physiology to clinical application in thoracic surgery. Saudi J Anaesth. 2021 Jul-Sep;15(3):250-263. doi: 10.4103/sja.sja_1216_20. Epub 2021 Jun 19.
PubMed 34764832Kim D, Lee C, Bae H, Kim J, Oh EJ, Jeong JS. Comparison of the perfusion index as an index of noxious stimulation in monitored anesthesia care of propofol/remifentanil and propofol/dexmedetomidine: a prospective, randomized, case-control, observational study. BMC Anesthesiol. 2023 May 26;23(1):183. doi: 10.1186/s12871-023-02116-x.
PubMed 37237353Mahmoud M, Barbi E, Mason KP. Dexmedetomidine: What's New for Pediatrics? A Narrative Review. J Clin Med. 2020 Aug 24;9(9):2724. doi: 10.3390/jcm9092724.
PubMed 32846947De Cassai A, Boscolo A, Geraldini F, Zarantonello F, Pettenuzzo T, Pasin L, Iuzzolino M, Rossini N, Pesenti E, Zecchino G, Sella N, Munari M, Navalesi P. Effect of dexmedetomidine on hemodynamic responses to tracheal intubation: A meta-analysis with meta-regression and trial sequential analysis. J Clin Anesth. 2021 Sep;72:110287. doi: 10.1016/j.jclinane.2021.110287. Epub 2021 Apr 16.
PubMed 33873003Khddam A, Rostom F, Hajeer MY. Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt (Qs/Qt) During One-Lung Ventilation in Pediatric Surgery: A Randomized Controlled Trial. Cureus. 2024 Mar 22;16(3):e56693. doi: 10.7759/cureus.56693. eCollection 2024 Mar.
PubMed 38523877Wang Y, Gong C, Yu F, Zhang Q. Effect of dexmedetomidine on intrapulmonary shunt in patients with sevoflurane maintained during one-lung ventilation: A case-control study. Medicine (Baltimore). 2022 Nov 18;101(46):e31818. doi: 10.1097/MD.0000000000031818.
PubMed 36401465Asri 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 32309196Xu 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 32547872Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870.
PubMed 35510198
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06505772
- Acronym / sponsor ID
- UDMS-Anesth-02-2024
- Conditions
- One-Lung Ventilation, Thoracic Surgery
- Keywords
- Hypoventilation pulmonary vasoconstriction HPV, Pulmonary shunt fraction Qs/Qt, Dexmedetomidine, partial pressure of arterial oxygen (PaO2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- University Children's Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Jul 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| The dexmedetomidine group | Experimental | Drug: DexmedetomidineDexmedetomidine: An initial dose of 0.5 mcg/kg of dexmedetomidine will be given over 10 minutes, starting 10 minutes after the initiation of anesthesia infusion. Following the initial dose, a continuous infusion of dexmedetomidine will be administered at a rate of 0.4 mcg/kg/hour. The infusion will be stopped before skin closure. |
| The Placebo group (the control group): | Placebo comparator | Drug: Normal salineSaline Solution (Placebo): After the induction of anesthesia, a volume of saline solution equivalent to the volume of dexmedetomidine used in the experimental group will be administered using the same protocol. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (7 listed)
- renal failure.
- hepatic dysfunction.
- congenital and valvular cardiac disease.
- neurological illnesses.
- During surgery, individuals who did not achieve complete lung isolation were excluded.
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 ) 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. | Drug | The dexmedetomidine group |
| Normal salineAlso: PlaceboNormal 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. | Drug | The Placebo group (the control group): |
Primary outcome
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.
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.
3 secondary outcomes
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.
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.
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.
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 23 Jul 2024.
- Background: PubMed 34764832Licker M, Hagerman A, Jeleff A, Schorer R, Ellenberger C. The hypoxic pulmonary vasoconstriction: From physiology to clinical application in thoracic surgery. Saudi J Anaesth. 2021 Jul-Sep;15(3):250-263. doi: 10.4103/sja.sja_1216_20. Epub 2021 Jun 19.
- Background: PubMed 37237353Kim D, Lee C, Bae H, Kim J, Oh EJ, Jeong JS. Comparison of the perfusion index as an index of noxious stimulation in monitored anesthesia care of propofol/remifentanil and propofol/dexmedetomidine: a prospective, randomized, case-control, observational study. BMC Anesthesiol. 2023 May 26;23(1):183. doi: 10.1186/s12871-023-02116-x.
- Background: PubMed 32846947Mahmoud M, Barbi E, Mason KP. Dexmedetomidine: What's New for Pediatrics? A Narrative Review. J Clin Med. 2020 Aug 24;9(9):2724. doi: 10.3390/jcm9092724.
- Background: PubMed 33873003De Cassai A, Boscolo A, Geraldini F, Zarantonello F, Pettenuzzo T, Pasin L, Iuzzolino M, Rossini N, Pesenti E, Zecchino G, Sella N, Munari M, Navalesi P. Effect of dexmedetomidine on hemodynamic responses to tracheal intubation: A meta-analysis with meta-regression and trial sequential analysis. J Clin Anesth. 2021 Sep;72:110287. doi: 10.1016/j.jclinane.2021.110287. Epub 2021 Apr 16.
- Background: PubMed 38523877Khddam A, Rostom F, Hajeer MY. Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt (Qs/Qt) During One-Lung Ventilation in Pediatric Surgery: A Randomized Controlled Trial. Cureus. 2024 Mar 22;16(3):e56693. doi: 10.7759/cureus.56693. eCollection 2024 Mar.
- Background: PubMed 36401465Wang Y, Gong C, Yu F, Zhang Q. Effect of dexmedetomidine on intrapulmonary shunt in patients with sevoflurane maintained during one-lung ventilation: A case-control study. Medicine (Baltimore). 2022 Nov 18;101(46):e31818. doi: 10.1097/MD.0000000000031818.
- 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 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.
- Background: PubMed 35510198Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870.
- Individual participant dataSharing planned: No
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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
Department of Anesthesiology Faculty of Medicine Damascus University
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 and Normal saline in people with One-Lung Ventilation and Thoracic Surgery, 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 3 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 23 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
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.). 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 NCT06505772, 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 23 Jul 2024.