AnesthesiaNCT07272044
Research on Anesthesia Depth Control Strategy Based on Continuous and Non-invasive Monitoring of Exhaled Breath
An observational study of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2024to 15 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent general anesthesia for the first time and combined intravenous and inhalational anesthesia
Who may be able to join
- Age ≥18 years old
- ASA I-III
- Expected duration of surgery > 1 hour
- Radial artery catheterization was performed
- Patients requiring BIS monitoring.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing the first intravenous-inhalation combined anesthesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1day
Secondary outcomes (2)
Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics
Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics detected by GC-SAW system
Measured: 1day
The incidence of adverse reactions
The occurrence of adverse reactions such as postoperative cognitive dysfunction, postoperative nausea and vomiting, chills, and delayed awakening within 72 hours after the operation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start16 Mar 2024
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272044
- Sponsor's protocol ID
- 2023-1166
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Anesthesia Depth Control Strategy Based on Continuous and Non-invasive Monitoring of Exhaled Breath
- ClinicalTrials.gov ID
- NCT07272044
- Acronym / sponsor ID
- 2023-1166
- Conditions
- Anesthesia
- Keywords
- Propofol, Breath testing, anesthesia monitoring, Bispectral Index, intravenous and inhalational anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing the first intravenous-inhalation combined anesthesia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent general anesthesia for the first time and combined intravenous and inhalational anesthesia
Key inclusion criteria (5 listed)
- Age ≥18 years old
- ASA I-III
- Expected duration of surgery > 1 hour
- Radial artery catheterization was performed
- Patients requiring BIS monitoring.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengjiang Zhang (18875213201, zrzfj@edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation and consistency analysis between exhaled breath concentrations of two anesthetics and BIS values (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.