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Status unknownNCT05611411MaACesrUpdated Feb 23, 2023

Maximum Alveolar Concentration of Sevoflurane for Maintaining Effective Spontaneous Respiration

An observational study in Sevoflurane, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
70
Ages
20 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sevoflurane
03

In context

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients scheduled for elective surgery under general anesthesia with tracheal intubation,with better general situation.

Inclusion criteria

  1. Age 20-60 years old
  2. ASA gradeⅠ\~Ⅱ
  3. Scheduled for elective surgery under general anesthesia with tracheal intubation

Exclusion criteria

Exclusion Criteria:

  1. Elective head and neck and chest surgery patients;
  2. Chronic respiratory disease or acute respiratory infection;
  3. Indication of difficult airway during preoperative visit;
  4. Risk of reflux aspiration;
  5. Did not receive regular antihypertensive therapy or blood pressure was not well controlled;
  6. Severe organic heart disease;
  7. Abnormal function of liver and kidney;
  8. Allergic to inhaled anesthetics and known or suspected genetic history of malignant hyperthermia;
  9. Mental disorders or long-term history of taking psychotropic drugs and cognitive impairment;
  10. History of drug abuse and alcohol abuse;
  11. Pregnant or nursing;
  12. Participated in any clinical trial as a subject within the last 3 months;
  13. Refuse to participate or do not sign or refuse to sign an informed consent form;
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. MaACesr

    maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration

    Time frame: 2022.12.01-2023.06.01

07

Study locations

1 of 1 sites recruiting
  • the Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05611411
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
SanQing Jin (Chief anesthesiologist, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Nov 10, 2022
Start date
Dec 1, 2022
Primary completion
Nov 3, 2023 (estimated)
Completion
Dec 6, 2023 (estimated)
Last update
Feb 23, 2023

Study contacts

洁琳 郑
Contact
962536345@qq.com
18359188309

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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