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

NCT07272044 | Recruiting

• 1 other identifier: 2023-1166
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Keywords

Propofol; Breath testing; anesthesia monitoring; Bispectral Index; intravenous and inhalational anesthesia

Outcome Measures

Primary Outcomes (2)

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

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

  1 day

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

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

  1day

Secondary Outcomes (2)

• Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics

  1day

• The incidence of adverse reactions

  72 hours

Study Arms (1)

Patients undergoing the first intravenous-inhalation combined anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent general anesthesia for the first time and combined intravenous and inhalational anesthesia

You may qualify if:

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

You may not qualify if:

• 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
• patients who did not wake up in PACU

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Residual blood was analyzed by intraoperative blood gas analysis

Central Study Contacts

Fengjiang Zhang

CONTACT

18875213201; zrzfj@edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: December 9, 2025
• Study Start: March 16, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-06

Locations

CN (1)