Control of anesthesia depth using continuous, non-invasive breath monitoring.
Official title: Research on Anesthesia Depth Control Strategy Based on Continuous and Non-invasive Monitoring of Exhaled Breath
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07272044 · Data updated 2026-11-12
This project tests whether continuous, non-invasive measurements of exhaled sevoflurane and propofol can predict BIS and guide anesthesia depth for adults having combined intravenous–inhalational surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | March 16, 2024 |
| Main results expected | March 15, 2027 |
| Study ends | March 15, 2029 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT07272044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) undergoing combined intravenous–inhalational surgery lasting more than one hour, ASA I–III, who require BIS monitoring and have radial artery catheterization are the intended participants.
✕Probably not a fit
Patients with contraindications to general anesthesia, pregnant patients, those with severe psychiatric or neurologic disorders, long-term antiepileptic or psychotropic drug use, or who refuse participation are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will record real-time concentrations of exhaled sevoflurane and propofol in adults undergoing combined intravenous–inhalational anesthesia and compare them with simultaneous BIS values. Researchers will build prediction models to estimate BIS from breath concentrations and analyze the relationship between anesthetic levels and depth of anesthesia across patient subgroups. The method is intended as an alternative monitoring strategy for patients who cannot use standard BIS sensors. Recruitment is limited to adults (≥18 years) with ASA I–III status, expected surgery duration over one hour, and radial artery catheterization at a single hospital in Hangzhou.
Why it matters
Potential benefit: If successful, this approach could let clinicians monitor and adjust anesthesia depth non-invasively when BIS is unavailable, improving safety and dosing precision.
How similar studies have gone: Previous work has linked inhalational anesthetic concentrations with BIS, but using continuous exhaled propofol measurements to predict BIS is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Fengjiang Zhang
- Email: zrzfj@edu.cn
- Phone: 18875213201
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.