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Recruiting NCT07272044

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

Observational Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Correlation and consistency analysis between exhaled breath concentrations of two anesthetics and BIS values [Time frame: 1 day]
  • Establish a 3D drug dose-effect model of the exhaled concentration and BIS value of anesthetics [Time frame: 1day]
Secondary outcome measures (2)
  • Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics [Time frame: 1day]
  • The incidence of adverse reactions [Time frame: 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT07272044 · 2023-1166

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗