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Comparative analysis of the performance of monitoring the sedation depth of total intravenous anesthesia with remimazolam based on EEG parameters

Comparative analysis of the performance of monitoring the sedation depth of total intravenous anesthesia with remimazolam based on EEG parameters

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094354
Enrollment
Unknown
Registered
2024-12-20
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Non-cardiac diseases

Interventions

Observation group:None

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Patients expected to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation; (2)Age >= 18 years; (3)ASA grade I~III; (4)Voluntary participation in this clinical trial with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Have a history of neurological or psychiatric illness or recent use of drugs affecting the central nervous system; (2) Patients with preoperative cognitive dysfunction determined by MMSE scale; (3) Those with severe impairment of auditory, visual and language system functions; (4) Those with severe impairment of heart, lung, kidney and liver function; (5) Identifying/suspected of abusing or long-term use of narcotic sedative analgesics; (6) Those who are allergic to conventional anesthetic drugs or have contraindications; (7) Body weight less than 70% or more than 130% of ideal body weight; (8) Postoperative coma or epilepsy; (9) Patients with difficult airways requiring awake intubation or who have been diagnosed with moderate to severe OSAS; (10) Those who are abstaining from alcohol; (11) Those who participated in other clinical studies during the same period.

Design outcomes

Primary

MeasureTime frame
Correlation between Electroencephalography parameters and sedation depth of remimazolam;

Secondary

MeasureTime frame
Correlation and consistency between anesthesia depth index(Ai) and bispectral index(BIS);Correlation Between Anesthesia depth index (Ai), Bispectral Index (BIS), and End-Tidal Carbon Dioxide Levels Under Total Intravenous Anesthesia with Remimazolam;

Countries

China

Contacts

Public ContactLi Hong

The Second Affiliated Hospital of Army Medical University

lh78553@163.com+86 136 0838 0123

Outcome results

None listed

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