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Study on appropriate dose and safety and efficacy of remazolam besylate for painless colonoscopy

Study on appropriate dose and safety and efficacy of remazolam besylate for painless colonoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052615
Enrollment
Unknown
Registered
2021-11-02
Start date
2021-11-10
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Colorectal disease

Interventions

Group A:0.2mg/kg Remimazolam was used as the induction dose
Group C:2mg/kg Propofol was used as the induction dose
Group B:0.25mg/kg Remimazolam was used as the induction dose

Sponsors

Hangzhou First People's Hospital affiliated to Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. ASA class I or II; 2. BMI 18-28kg/m2; 3. Aged 18 to 65 years; 4. Patients receiving routine colonoscopy diagnosis and treatment.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women and patients (including men) with birth plans within 3 months; 2.Patients with obvious respiratory and circulatory dysfunction, abnormal blood routine and biochemical indexes before surgery; 3.Persons suffering from severe neuropsychiatric disorders; 4.Take benzodiazepines or opioids every day for 1 month or intermittenously for the last 3 months; 5.Allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone and other drugs and their components; 6.Patients assessed as having difficulty in respiratory management: modified Martensite score III or above.

Design outcomes

Primary

MeasureTime frame
Improved alertness/sedation score;Body dynamic response;awakening time;Reach the standard departure time;

Secondary

MeasureTime frame
blood pressure;oxygen saturation;heart rate;respiratory rate;

Countries

China

Contacts

Public ContactSun Qirui

Hangzhou First People's Hospital affiliated to Zhejiang University

2516470351@qq.com+86 15397433938

Outcome results

None listed

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