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Safety and efficacy of Remimazolam besylate combined with alfentanil for painless flexible bronchoscopy

Safety and efficacy of Remimazolam besylate combined with alfentanil for painless flexible bronchoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071207
Enrollment
Unknown
Registered
2023-05-08
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

None listed

Interventions

Group A:Intravenous alfentanil 15 µg/kg, remimazolam 0.33 mg/kg
Group B:Intravenous remifentanil 2 µg/kg, remimazolam 0.33 mg/kg
Group C:Intravenous alfentanil 15 µg/kg, propofol 2.5 mg/kg
Group D:Intravenous remifentanil 2 µg/kg, propofol 2.5 mg/kg

Sponsors

The Second Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients receiving painless fibrobronchoscopy; 2. Aged 18~65 years, no gender limit; 3. ASA?~?; 4. BMI: 18~30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Contraindications to general anesthesia; 2. Cardiac function > Grade 3 with a history of severe cardiovascular disease; Unstable angina pectoris, or myocardial plug within the last 6 months; 3. Acute upper respiratory tract infection, asthma attack or acute severe laryngeal disease; 4. Hypertension with unsatisfactory blood pressure control (recumbent systolic blood pressure >=180 mmHg, and/or diastolic blood pressure >=110 mmHg during screening); 5. A history of alcohol abuse and chronic use of sedatives and opiates; 6. Pregnancy or lactation; 7. Liver and kidney dysfunction; 8. History of mental disorders; 9. The researcher decided that it was not suitable to participate in the experiment; 10. The treatment time of fibrobronchoscopy was more than 1 hour.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;The number of drug refills;

Secondary

MeasureTime frame
The observer's assessment of alertness/sedation scale;Postoperative recovery time;Vital signs and perioperative adverse events;Time of leave;Ramsay sedation score;

Countries

China

Contacts

Public ContactWang Zhao

The Second Affiliated Hospital of Zunyi Medical University

286423026@qq.com+86 13984282588

Outcome results

None listed

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