Skip to content

A prospective randomized controlled trial of the efficacy and safety of remimazolam besylate in fiberoptic bronchoscopy in the ICU

A prospective randomized controlled trial of the efficacy and safety of remimazolam besylate in fiberoptic bronchoscopy in the ICU

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050181
Enrollment
Unknown
Registered
2021-08-21
Start date
2021-09-15
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

ICU sedation

Interventions

experimental group 1:The initial dose of Remimazolam besylate was 5mg, and the additional dose was 2.5mg/ time
experimental group 2:The initial dose of propofol was 1.5mg/kg, and the additional dose was 0.5mg/kg/ time

Sponsors

The Third Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who intend to undergo fiberoptic bronchoscopy; 2. ASA I-III level; 3. Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with sedation/anaesthesia contraindications or have a history of abnormal surgical anesthesia recovery; 2. Allergic to local anaesthetics,propofol, benzodiazepines , opioids and their antagonist; 3. Patients with severe heart, brain, lung, liver, kidney and metabolic diseases; 4. Subjects deemed unsuitable to participate in this research by the researcher.

Design outcomes

Primary

MeasureTime frame
Moderate sedation and success rate were achieved ;

Secondary

MeasureTime frame
Time to return to pre-test levels of consciousness;Number of cases in which remedial drugs were administered;Degree of satisfaction investigation;Dose explore;

Countries

China

Contacts

Public ContactAn Yuling

Department of Critical Care Medicine, the Third Affiliated Hospital, Sun Yat-sen University

anyuling929@163.com+86 15975636217

Outcome results

None listed

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