NCT05611411

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

November 6, 2022

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • MaACesr

    maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration

    2022.12.01-2023.06.01

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief anesthesiologist

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 10, 2022

Study Start

December 1, 2022

Primary Completion

November 3, 2023

Study Completion

December 6, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations