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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07272044

Enrollment

500

Registered

2025-12-09

Start date

2024-03-16

Completion date

2029-03-15

Last updated

2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation and consistency analysis between exhaled breath concentrations of two anesthetics and BIS values	1 day	Correlation and consistency analysis between exhaled breath concentrations of two anesthetics detected by GC-SAW system and BIS values
Establish a 3D drug dose-effect model of the exhaled concentration and BIS value of anesthetics	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

Measure	Time frame	Description
Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics	1day	Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics detected by GC-SAW system
The incidence of adverse reactions	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

Countries

China

Contacts

Primary ContactFengjiang Zhang

zrzfj@edu.cn18875213201

Outcome results