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Comparison of Bispectral Index During Remimazolam and Propofol Sedation

Comparison of Bispectral Index During Remimazolam and Propofol Sedation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112548
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-11-25
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Sedation

Interventions

AB group:First receive propofol sedation, followed by remimazolam sedation after a washout period of at least 1 week.
BA group:First receive remimazolam sedation, followed by propofol sedation after a washout period of at least 1 week.

Sponsors

Sanming First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Healthy volunteer. 2. Aged 18 to 45 years old. 3. American Society of Anesthesiologists (ASA) physical status I.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or allergy to the investigational drug. 2. History of chronic alcohol or substance abuse (including benzodiazepines or opioids). 3. Intake of medications affecting the central nervous system within 72 hours prior to enrollment. 4. A history of neurological or psychiatric disorders. 5. Women who are pregnant, lactating, or currently menstruating. 6. Any condition that may interfere with study outcomes, such as language comprehension difficulties or communication barriers.

Design outcomes

Primary

MeasureTime frame
The bispectral index during the deep sedation phase ;

Secondary

MeasureTime frame
The bispectral index at the loss of eyelash reflex ;The bispectral index during the moderate sedation phase ;Cognitive function;Emergence time;

Countries

China

Contacts

Public ContactHuifen Lin

Sanming First Hospital

306246774@qq.com+86 135 0756 9176

Outcome results

None listed

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