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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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;
Show all 13Show fewer
  • 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.

洁琳 郑 contact

18359188309

962536345@qq.com

China1 site, 1 recruiting
  • the Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    SanQing Jin, MD, 0086-13719366863, sanqingjin@hotmail.com

    Recruiting

Other trials in China

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.

  1. 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.

  1. First posted10 Nov 2022
  2. Study start1 Dec 2022
  3. Primary completion3 Nov 2023 (estimated)
  4. Study completion6 Dec 2023 (estimated)

Resources

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)
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

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.

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