One-Lung VentilationNCT05907525
Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation
A study testing Remimazolam and 1% propofol in people with One-Lung Ventilation and Thoracic Surgery, Video-Assisted, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- One-Lung Ventilation, Thoracic Surgery, Video-Assisted, Remimazolam
- What is being tested?
- Remimazolam and 1% propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2023to 15 Apr 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing video-assisted thoracoscopic surgery
- 19 years of age or older, less than 80 years old
- The American Society of Anesthesiologists (ASA) classification I-Ⅲ physical status
Who cannot join
- Patients with known allergy to benzodiazepine, propofol
- Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Patients with hypersensitivity to Dextran40
- Patients with end stage renal disease requiring hemodialysis
- Patients with history of acute angle glaucoma
- Emergency operation
Show all 10Show fewer
- Patients with unstable hemodynamics requiring inotropics
- Patients with preoperative oxygen supplement
- Preoperative forced expiratory volume (FEV1) less than 40% of predicted
- Preoperative ejection fraction less than 50%
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Please Select, 50612
About this study
Official title: Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation: a Prospective Randomized Controlled Study
The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
Read the detailed description
One lung ventilation (OLV) is a mechanical ventilation method used during thoracic surgery to collapse the non-ventilated lung and secure the surgical field. During one lung ventilation, the pulmonary artery of the collapsed lung undergoes vasoconstriction in response to hypoxia, which increases the blood flow of the normally ventilated lung as a compensatory physiological response. This is known as hypoxic pulmonary vasoconstriction (HPV). Therefore, by using HPV, arterial blood oxygenation can be maintained and pulmonary shunting can be reduced, preventing hypoxemia during one lung ventilation.
The two most commonly used anesthetics in thoracic surgery are sevoflurane, an inhaled anesthetic, and propofol, an intravenous anesthetic. Previous studies have shown that there were no significant differences between two anesthetics on arterial oxygenation during one lung ventilation because sevoflurane administered in clinical concentrations of 1 minimum alveolar concentration (MAC) resulted in similar changes in shunt fraction as did propofol.
However, the effect of remimazolam on arterial blood oxygenation and intrapulmonary shunt during one lung ventilation has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and sevoflurane anesthesia on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
- Being tested
- Remimazolam, 1% propofol
- Keywords
- remimazolam, one-lung ventilation, arterial oxygenation, hypoxic pulmonary vasoconstriction, sevoflurane, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Byfavo
To induce anesthesia, remimazolam is continuously infused in a dose of 6mg/kg/hr with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). Maintenance dose of remimazolam is 1mg/kg/hr, up to 2mg/kg/hr, and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia.
Inspired oxygen fraction (FiO2) 1.0 is used during mask ventilation and tracheal intubation. During two lung ventilation (TLV), tidal volumes (8mL/kg predicted body weight), positive end-expiratory pressure (PEEP) 5cmH2O with FiO2 0.3 is applied. At the start of one lung ventilation(OLV), tidal volumes (5mL/kg predicted body weight), PEEP 5cmH2O with FiO2 0.8 is applied. Intraoperative ventilatory frequency is 12 breaths/min, subsequently adjusted to maintain end tidal CO2(ETCO2) ranged between 35-40mmHg.
1% propofolDrug
Also called Fresofol MCT 1%
To induce anesthesia, 1% propofol 1.5-2.5mg/kg is used with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). After patient loses consciousness, anesthesia is maintained through the inhalation of sevoflurane between 1-2 minimum alveolar concentrations (MAC), and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia.
Inspired oxygen fraction (FiO2) 1.0 is used during mask ventilation and tracheal intubation. During two lung ventilation (TLV), tidal volumes (8mL/kg predicted body weight), positive end-expiratory pressure (PEEP) 5cmH2O with FiO2 0.3 is applied. At the start of one lung ventilation(OLV), tidal volumes (5mL/kg predicted body weight), PEEP 5cmH2O with FiO2 0.8 is applied. Intraoperative ventilatory frequency is 12 breaths/min, subsequently adjusted to maintain end tidal CO2(ETCO2) ranged between 35-40mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | To induce anesthesia, remimazolam is continuously infused in a dose of 6mg/kg/hr with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). Maintenance dose of remimazolam is 1mg/kg/hr, up to 2mg/kg/hr, and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. Receives: Drug: Remimazolam |
| Sevoflurane group | Active comparator | To induce anesthesia, 1% propofol 1.5-2.5mg/kg is used with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). After patient loses consciousness, anesthesia is maintained through the inhalation of sevoflurane between 1-2 minimum alveolar concentrations (MAC). Remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. Receives: Drug: 1% propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 after 30 minutes of OLV (T2)
compare the arterial oxygenation after 30 minutes of one lung ventilation between two groups
Measured: arterial blood sampling will be taken over four times: T0 (after 10 minute of TLV in lateral decubitus position), T1 (after 15 minutes of OLV), T2 (after 30 minutes of OLV), T3 (after 60 minutes of OLV)
Secondary outcomes (6)
Changes of PaO2
Compare the changes of PaO2 between two groups.
Measured: During 60 minutes of OLV
Changes of PaCO2
Compare the changes of PaCO2 between two groups.
Measured: During 60 minutes of OLV
Changes of P/F ratio
Compare the changes of PaO2/FiO2 ratio between two groups.
Measured: During 60 minutes of OLV
The lowest PaO2
Compare the lowest PaO2 between two groups.
Measured: During 60 minutes of OLV
Changes of ORI
Compare the changes of oxygen reserve index between two groups.
Measured: During 60 minutes of OLV
Changes of MAP
Compare the changes of mean arterial pressure between two groups.
Measured: During 60 minutes of OLV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start29 Jun 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD. PhD, Study chair, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907525
- Sponsor's protocol ID
- 05-2023-133
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05907525
- Acronym / sponsor ID
- 05-2023-133
- Keywords
- remimazolam, one-lung ventilation, arterial oxygenation, hypoxic pulmonary vasoconstriction, sevoflurane, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 18 Jun 2023 (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 goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
Detailed description
One lung ventilation (OLV) is a mechanical ventilation method used during thoracic surgery to collapse the non-ventilated lung and secure the surgical field. During one lung ventilation, the pulmonary artery of the collapsed lung undergoes vasoconstriction in response to hypoxia, which increases the blood flow of the normally ventilated lung as a compensatory physiological response. This is known as hypoxic pulmonary vasoconstriction (HPV). Therefore, by using HPV, arterial blood oxygenation can be maintained and pulmonary shunting can be reduced, preventing hypoxemia during one lung ventilation.
The two most commonly used anesthetics in thoracic surgery are sevoflurane, an inhaled anesthetic, and propofol, an intravenous anesthetic. Previous studies have shown that there were no significant differences between two anesthetics on arterial oxygenation during one lung ventilation because sevoflurane administered in clinical concentrations of 1 minimum alveolar concentration (MAC) resulted in similar changes in shunt fraction as did propofol.
However, the effect of remimazolam on arterial blood oxygenation and intrapulmonary shunt during one lung ventilation has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and sevoflurane anesthesia on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: RemimazolamTo induce anesthesia, remimazolam is continuously infused in a dose of 6mg/kg/hr with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). Maintenance dose of remimazolam is 1mg/kg/hr, up to 2mg/kg/hr, and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. |
| Sevoflurane group | Active comparator | Drug: 1% propofolTo induce anesthesia, 1% propofol 1.5-2.5mg/kg is used with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). After patient loses consciousness, anesthesia is maintained through the inhalation of sevoflurane between 1-2 minimum alveolar concentrations (MAC). Remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing video-assisted thoracoscopic surgery
- 19 years of age or older, less than 80 years old
- The American Society of Anesthesiologists (ASA) classification I-Ⅲ physical status
Key exclusion criteria (10 listed)
- Patients with known allergy to benzodiazepine, propofol
- Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Patients with hypersensitivity to Dextran40
- Patients with end stage renal disease requiring hemodialysis
- Patients with history of acute angle glaucoma
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 |
|---|---|---|
| RemimazolamAlso: ByfavoTo induce anesthesia, remimazolam is continuously infused in a dose of 6mg/kg/hr with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). Maintenance dose of remimazolam is 1mg/kg/hr, up to 2mg/kg/hr, and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. Inspired oxygen fraction (FiO2) 1.0 is used during mask ventilation and tracheal intubation. During two lung ventilation (TLV), tidal volumes (8mL/kg predicted body weight), positive end-expiratory pressure (PEEP) 5cmH2O with FiO2 0.3 is applied. At the start of one lung ventilation(OLV), tidal volumes (5mL/kg predicted body weight), PEEP 5cmH2O with FiO2 0.8 is applied. Intraoperative ventilatory frequency is 12 breaths/min, subsequently adjusted to maintain end tidal CO2(ETCO2) ranged between 35-40mmHg. | Drug | Remimazolam group |
| 1% propofolAlso: Fresofol MCT 1%To induce anesthesia, 1% propofol 1.5-2.5mg/kg is used with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). After patient loses consciousness, anesthesia is maintained through the inhalation of sevoflurane between 1-2 minimum alveolar concentrations (MAC), and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. Inspired oxygen fraction (FiO2) 1.0 is used during mask ventilation and tracheal intubation. During two lung ventilation (TLV), tidal volumes (8mL/kg predicted body weight), positive end-expiratory pressure (PEEP) 5cmH2O with FiO2 0.3 is applied. At the start of one lung ventilation(OLV), tidal volumes (5mL/kg predicted body weight), PEEP 5cmH2O with FiO2 0.8 is applied. Intraoperative ventilatory frequency is 12 breaths/min, subsequently adjusted to maintain end tidal CO2(ETCO2) ranged between 35-40mmHg. | Drug | Sevoflurane group |
Primary outcome
PaO2 after 30 minutes of OLV (T2)
Time frame: arterial blood sampling will be taken over four times: T0 (after 10 minute of TLV in lateral decubitus position), T1 (after 15 minutes of OLV), T2 (after 30 minutes of OLV), T3 (after 60 minutes of OLV)
compare the arterial oxygenation after 30 minutes of one lung ventilation between two groups
6 secondary outcomes
Changes of PaO2
Time frame: During 60 minutes of OLV
Changes of PaCO2
Time frame: During 60 minutes of OLV
Changes of P/F ratio
Time frame: During 60 minutes of OLV
The lowest PaO2
Time frame: During 60 minutes of OLV
Changes of ORI
Time frame: During 60 minutes of OLV
Changes of MAP
Time frame: During 60 minutes 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 12 Aug 2024.
- 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.
Hee Young Kim, MD. PhD study chair
Pusan National University Yangsan 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 Remimazolam and 1% propofol in people with One-Lung Ventilation and Thoracic Surgery, Video-Assisted, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 10 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 12 Aug 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 South Korea. 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?
PaO2 after 30 minutes of OLV (T2) (time frame: arterial blood sampling will be taken over four times: T0 (after 10 minute of TLV in lateral decubitus position), T1 (after 15 minutes of OLV), T2 (after 30 minutes of OLV), T3 (after 60 minutes of OLV)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2024.