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A Comparative Study on the Accuracy of Narcotrend Index, Patient State Index, and Bispectral Index in Monitoring the Sedation Depth of Remimazolam

A Comparative Study on the Accuracy of Narcotrend Index, Patient State Index, and Bispectral Index in Monitoring the Sedation Depth of Remimazolam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104672
Enrollment
Unknown
Registered
2025-06-20
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None

Interventions

B(BIS) group:BIS electrodes were attached and monitored using the Covidien EEG bispectral index monitor BIS VISTA.
P(PSI) group:Sedline electrodes were attached and monitored using the Masimo SedLine? Brain Function Monitor.
NT(Narcotrend) group:Attach the NI electrodes and monitor them with a Narcotrend monitor.

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 65 years, regardless of gender; 2.BMI 18.5-30 kg/m^2; 3.ASA class I, II, III; 4.Subjects scheduled for elective general anesthesia surgery requiring endotracheal intubation; 5.Non-acute hospitalized subjects who have undergone appropriate preoperative preparation.

Exclusion criteria

Exclusion criteria: 1.Individuals with chronic pain who have long-term use of analgesics, psychiatric system medications (including opioids, NSAIDs, sedatives, antidepressants), or alcohol abuse; 2. Those with a body weight 15% below or above the standard weight; 3. Preoperative abnormal increase in liver and kidney function (ALT, AST, BUN, Cr); 4. History of abnormal recovery from surgical anesthesia; 5. History of hypertension or cerebrovascular accident; 6. Use of sedatives, analgesics, or antipruritic drugs within 24 hours before surgery; 7. Allergy to electrode patches or gel; 8. Use of monoamine oxidase inhibitors or antidepressants within 15 days; 9. Participation in other drug trials within three months.

Design outcomes

Primary

MeasureTime frame
Bispectral Index;Patient State Index;Narcotrend;

Secondary

MeasureTime frame
EEG parameters.;

Countries

China

Contacts

Public ContactDandan Tian

The First Affiliated Hospital of Zhengzhou University

gezw1101@163.com+86 139 3907 1527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026