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NCT Number: NCT07272044

Research on Anesthesia Depth Control Strategy Based on Continuous and Non-invasive Monitoring of Exhaled Breath

This study aims to propose a strategy for controlling the depth of anesthesia based on continuous and non-invasive monitoring of exhaled breath: BIS value during intravenous-inhalation combined anesthesia is predicted according to the real-time exhaled concentrations of sevoflurane and propofol, so as to achieve the depth of anesthesia management for patients who cannot use standard BIS. Furthermore, the relationship between anesthetic concentration and depth of anesthesia was analyzed in different subgroups.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old
  • ASA I-III
  • Expected duration of surgery > 1 hour
  • Radial artery catheterization was performed
  • Patients requiring BIS monitoring.

Exclusion criteria

  • Patients with contraindications to general anesthesia
  • mental disorder, unable to answer
  • long-term use of antiepileptic drugs and psychotropic drugs
  • pregnant patients
  • patients refused to participate
  • the investigator thought that the study was not suitable for inclusion
  • patients who did not wake up in PACU

Treatment and study plan

Primary outcomes

  1. Correlation and consistency analysis between exhaled breath concentrations of two anesthetics and BIS values

    Time frame: 1 day

    Correlation and consistency analysis between exhaled breath concentrations of two anesthetics detected by GC-SAW system and BIS values

  2. Establish a 3D drug dose-effect model of the exhaled concentration and BIS value of anesthetics

    Time frame: 1day

    Establish a 3D drug dose-effect model based on the exhaled gas concentration of anesthetics detected by the GC-SAW system and BIS value

Secondary outcomes

  1. Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics

    Time frame: 1day

    Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics detected by GC-SAW system

  2. The incidence of adverse reactions

    Time frame: 72 hours

    The occurrence of adverse reactions such as postoperative cognitive dysfunction, postoperative nausea and vomiting, chills, and delayed awakening within 72 hours after the operation

Study contacts

Contact information is provided by the study sponsor or research team.

Fengjiang Zhang

CONTACT

[email protected]

18875213201

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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