Comparative analysis of BIS correlation index in sedation between remimazolam and propofol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062413

Enrollment

Unknown

Registered

2022-08-05

Start date

2022-08-01

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

Colonic polyps

Interventions

Group AP:Alfentanil 10µg/kg+propofol 2mg/kg

Group AR:Alfentanil 10µg/kg+remimazolam 0.15mg/kg

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. ASA I-II; 3. The operation time was 20 minutes to 1 hour; 4. BMI 18.5~23.9kg/m2; 5. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency operation; 2. Patients with high risk of gastric fullness and reflux aspiration; 3. Allergic to benzodiazepines and opioids; 4. Those who took sedative, analgesic or antidepressant drugs within 24 hours; 5. Pregnant and lactating women; 6. Abnormal liver and kidney function; 7. Previous drug use history; 8. Recently participated in other clinical studies; 9. Patients who can't cooperate with communication.

Design outcomes

Primary

Measure	Time frame
Bispectral index, BIS;EMG;Spectral Edge Frequency, 95% SEF;	—

Countries

China

Contacts

Public ContactXu Aijun

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

ajxu@tjh.tjmu.edu.cn+86 027-83663173

Outcome results

None listed

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