SevofluraneMaACesrNCT05611411
Maximum Alveolar Concentration of Sevoflurane for Maintaining Effective Spontaneous Respiration
An observational study of Sevoflurane, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Mechanical ventilation will bring many adverse effects. Positive pressure can affect hemodynamics. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Sevoflurane
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 6 Dec 2023
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients scheduled for elective surgery under general anesthesia with tracheal intubation,with better general situation.
Who may be able to join
- Age 20-60 years old
- ASA gradeⅠ~Ⅱ
- Scheduled for elective surgery under general anesthesia with tracheal intubation
Who cannot join
- Elective head and neck and chest surgery patients;
- Chronic respiratory disease or acute respiratory infection;
- Indication of difficult airway during preoperative visit;
- Risk of reflux aspiration;
- Did not receive regular antihypertensive therapy or blood pressure was not well controlled;
- Severe organic heart disease;
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- Abnormal function of liver and kidney;
- Allergic to inhaled anesthetics and known or suspected genetic history of malignant hyperthermia;
- Mental disorders or long-term history of taking psychotropic drugs and cognitive impairment;
- History of drug abuse and alcohol abuse;
- Pregnant or nursing;
- Participated in any clinical trial as a subject within the last 3 months;
- Refuse to participate or do not sign or refuse to sign an informed consent form;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
SanQing Jin, MD, 0086-13719366863, sanqingjin@hotmail.com
About this study
Official title: The Exploration of Maximum Alveolar Concentration of Sevoflurane for Maintaining Effective Spontaneous Respiration
Mechanical ventilation will bring many adverse effects. Positive pressure can affect hemodynamics. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Patients who are intubated and mechanically ventilated are at risk for ventilator-associated pneumonia. Mechanical ventilation can induce or aggravate lung injury, called ventilator-induced lung injury (VILI) , Minimizing the duration of mechanical ventilation is the best way to reduce complications.
Sevoflurane is a halogen group of inhaled anesthetics commonly used in clinical, with sedation, analgesia, muscle relaxation. Sevoflurane also inhibited respiratory function, tidal volume decreased with the depth of anesthesia, respiratory rate increased, higher than the conscious respiratory rate, but not enough to fully compensate for the decreased tidal volume. The results showed that with the increase of the depth of anesthesia, the minute ventilation decreased, and the ability to remove carbon dioxide also decreased.
Based on the background of the study and the pharmacological properties of sevoflurane, we sought to explore the maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration in patients, i.e.FiO2 = 30% , PaO2 > 92% , VT > 5 ml/kg, RR > 8/min, PETCO2 < 50 mmHg, sustained > 20s, the time from the beginning of inhalation induction to 1 point OAAS, the changes of hemodynamics during induction, and the recall of induction and operation were also explored.
Read the detailed description
Mechanical ventilation is the most widely used short-term life support technique in the world, which can not only provide good condition for anesthesiologists to manage airway, it can also prevent respiratory muscle fatigue and carbon dioxide accumulation caused by insufficient ventilation.
At the same time, mechanical ventilation will also bring a lot of adverse effects. Positive pressure ventilation can affect hemodynamics, and studies have shown that high intrathoracic pressure, especially high plateau pressure, can adversely affect right ventricular afterload and function. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Patients who are intubated and mechanically ventilated are at risk for ventilator-associated pneumonia due to low oral and pharyngeal secretions, reduced cough efficiency, and impaired mucociliary clearance. Mechanical ventilation can induce or aggravate lung injury, called ventilator-induced lung injury (VILI) .
Minimizing the duration of mechanical ventilation is the best way to reduce complications.
Sevoflurane is a halogen group of inhaled anesthetics commonly used in clinical, with sedation, analgesia, muscle relaxation. The blood/gas distribution coefficient is low and the effect is quick. The elimination mainly depends on the lung exhalation, about 5% passes through the liver metabolism, is affected by the anaesthesia time long little. Long-term low-flow sevoflurane inhalation anesthesia has little effect on liver and kidney function.
Sevoflurane also inhibited respiratory function, tidal volume decreased with the depth of anesthesia, respiratory rate increased, higher than the conscious respiratory rate, but not enough to fully compensate for the decreased tidal volume. The results showed that with the increase of the depth of anesthesia, the minute ventilation decreased, and the ability to remove carbon dioxide also decreased.
Based on the background of the study and the pharmacological properties of sevoflurane, we sought to explore the best alveolar concentration of sevoflurane for maintaining effective spontaneous respiration in patients, i.e. FiO2 = 30% , PaO2 > 92% , VT > 5 ml/kg, RR > 8/min, PETCO2< 50 mmHg, sustained > 20s, the time from the beginning of inhalation induction to 1 point OAAS, the changes of hemodynamics during induction, and the recall of induction and operation were also explored.
- Conditions
- Sevoflurane
What is being measured
The primary outcome is the main question the study is designed to answer.
MaACesr
maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration
Measured: 2022.12.01-2023.06.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Dec 2022
- Primary completion3 Nov 2023 (estimated)
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611411
- Sponsor's protocol ID
- 2022ZSLYEC-493
- Acronym
- MaACesr
- Status last verified
- Feb 2023
- First submitted
- 6 Nov 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploration of Maximum Alveolar Concentration of Sevoflurane for Maintaining Effective Spontaneous Respiration
- ClinicalTrials.gov ID
- NCT05611411
- Acronym / sponsor ID
- MaACesr / 2022ZSLYEC-493
- Conditions
- Sevoflurane
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 3 Nov 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 10 Nov 2022 (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.
Mechanical ventilation will bring many adverse effects. Positive pressure can affect hemodynamics. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Patients who are intubated and mechanically ventilated are at risk for ventilator-associated pneumonia. Mechanical ventilation can induce or aggravate lung injury, called ventilator-induced lung injury (VILI) , Minimizing the duration of mechanical ventilation is the best way to reduce complications.
Sevoflurane is a halogen group of inhaled anesthetics commonly used in clinical, with sedation, analgesia, muscle relaxation. Sevoflurane also inhibited respiratory function, tidal volume decreased with the depth of anesthesia, respiratory rate increased, higher than the conscious respiratory rate, but not enough to fully compensate for the decreased tidal volume. The results showed that with the increase of the depth of anesthesia, the minute ventilation decreased, and the ability to remove carbon dioxide also decreased.
Based on the background of the study and the pharmacological properties of sevoflurane, we sought to explore the maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration in patients, i.e.FiO2 = 30% , PaO2 > 92% , VT > 5 ml/kg, RR > 8/min, PETCO2 < 50 mmHg, sustained > 20s, the time from the beginning of inhalation induction to 1 point OAAS, the changes of hemodynamics during induction, and the recall of induction and operation were also explored.
Detailed description
Mechanical ventilation is the most widely used short-term life support technique in the world, which can not only provide good condition for anesthesiologists to manage airway, it can also prevent respiratory muscle fatigue and carbon dioxide accumulation caused by insufficient ventilation.
At the same time, mechanical ventilation will also bring a lot of adverse effects. Positive pressure ventilation can affect hemodynamics, and studies have shown that high intrathoracic pressure, especially high plateau pressure, can adversely affect right ventricular afterload and function. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Patients who are intubated and mechanically ventilated are at risk for ventilator-associated pneumonia due to low oral and pharyngeal secretions, reduced cough efficiency, and impaired mucociliary clearance. Mechanical ventilation can induce or aggravate lung injury, called ventilator-induced lung injury (VILI) .
Minimizing the duration of mechanical ventilation is the best way to reduce complications.
Sevoflurane is a halogen group of inhaled anesthetics commonly used in clinical, with sedation, analgesia, muscle relaxation. The blood/gas distribution coefficient is low and the effect is quick. The elimination mainly depends on the lung exhalation, about 5% passes through the liver metabolism, is affected by the anaesthesia time long little. Long-term low-flow sevoflurane inhalation anesthesia has little effect on liver and kidney function.
Sevoflurane also inhibited respiratory function, tidal volume decreased with the depth of anesthesia, respiratory rate increased, higher than the conscious respiratory rate, but not enough to fully compensate for the decreased tidal volume. The results showed that with the increase of the depth of anesthesia, the minute ventilation decreased, and the ability to remove carbon dioxide also decreased.
Based on the background of the study and the pharmacological properties of sevoflurane, we sought to explore the best alveolar concentration of sevoflurane for maintaining effective spontaneous respiration in patients, i.e. FiO2 = 30% , PaO2 > 92% , VT > 5 ml/kg, RR > 8/min, PETCO2< 50 mmHg, sustained > 20s, the time from the beginning of inhalation induction to 1 point OAAS, the changes of hemodynamics during induction, and the recall of induction and operation were also explored.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients scheduled for elective surgery under general anesthesia with tracheal intubation,with better general situation.
Key inclusion criteria (3 listed)
- Age 20-60 years old
- ASA gradeⅠ~Ⅱ
- Scheduled for elective surgery under general anesthesia with tracheal intubation
Key exclusion criteria (13 listed)
- Elective head and neck and chest surgery patients;
- Chronic respiratory disease or acute respiratory infection;
- Indication of difficult airway during preoperative visit;
- Risk of reflux aspiration;
- Did not receive regular antihypertensive therapy or blood pressure was not well controlled;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MaACesr
Time frame: 2022.12.01-2023.06.01
maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sevoflurane, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 13 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: status not confirmed, as of the sponsor's last update on 23 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 洁琳 郑 (18359188309, 962536345@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MaACesr (time frame: 2022.12.01-2023.06.01). 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 23 Feb 2023.