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The effectiveness and safety of remimazolam besylate for sedation in patients at risk of gastrointestinal bleeding: A single-center prospective randomized controlled study comparing with propofol.

The effectiveness and safety of remimazolam besylate for sedation in patients at risk of gastrointestinal bleeding: A single-center prospective randomized controlled study comparing with propofol.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074189
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

Acute Gastrointestinal Bleeding

Interventions

RM:Using remimazolam for sedation.
PP:Using propofol for sedation.

Sponsors

The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years, male or female; 2.Admitted to the ICU for gastrointestinal endoscopy or endoscopic treatment; 3.Preoperative American Society of Anesthesiologists (ASA) classification of grade II or above (Grade I: Healthy, well-nourished, normal organ functions; Grade II: Mild systemic disease, no functional limitations, no substantial organ dysfunction; Grade III: Severe systemic disease, limited physical activity, but able to carry out routine activities, with one or more moderate to severe diseases; Grade IV: Severe systemic disease that is a constant threat to life, incapacitated, unfit for any activity without the threat to life; Grade V: A moribund patient who is not expected to survive without the operation; Grade VI: A declared brain-dead patient whose organs are being removed for donor purposes); 4.Light to moderate sedation requirement; 5.Written informed consent provided by the subject or their legally authorized representative.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of severe myasthenia gravis, schizophrenia, severe dementia, and severe depression; 2.Patients with a history of allergic reactions to benzodiazepines or propofol; 3.Patients who are pregnant or breastfeeding; 4.Participants whom the researchers deem unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
RASS score;Incidence of intraoperative hypotension;Vital signs;Adverse reactions;MOAA/S score;

Secondary

MeasureTime frame
Anesthesia wake time;Time to reach target sedation level;Intubation;30-days and 90-days all-cause mortality;

Countries

China

Contacts

Public ContactWu Wen

The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People's Hospital

fly5wing@126.com+86 156 7254 0729

Outcome results

None listed

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