Skip to content

Observational Clinical Study of Remimazolam Besylate versus Propofol for Sedation in Critically Ill Patients Undergoing Operative Examinations

Observational Clinical Study of Remimazolam Besylate versus Propofol for Sedation in Critically Ill Patients Undergoing Operative Examinations

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122705
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

None

Interventions

Remimazolam besylate group:None

Sponsors

Shijiazhuang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Requiring procedural examinations due to clinical conditions, and in need of sedation during the procedure (sedation target: RASS score -2 to 0); 3.Voluntarily participating in the study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with primary life-threatening diseases, including unresectable malignant tumors with multiple metastases due to uncontrolled progression, hematological diseases, etc. 3. Patients who have continuously used immunosuppressants or undergone organ transplantation within the past 6 months; 4. Patients with known hypersensitivity to remimazolam besylate, propofol, or their excipients; 5. Severe hepatic or renal failure (liver function: Child-Pugh class C renal function: creatinine clearance < 10 mL/min, or requiring unstable renal replacement therapy); 6. Patients unable to complete analgesia and sedation assessment due to severe psychiatric history, schizophrenia, severe depression, end-stage disease, or any other conditions that interfere with the accurate evaluation of cognitive function; 7. Patients who participated in other clinical trials within the past 3 months; 8.Patients judged by the investigators as unable to complete or unsuitable for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Sedation onset time;Incidence of adverse reactions during the study period;Stability of sedation maintenance;

Secondary

MeasureTime frame
Recovery time;Vital signs(Systolic blood pressure (SBP)?Diastolic blood pressure (DBP)?Heart rate (HR)?Respiratory rate (RR)?Pulse oxygen saturation (SpO?));

Countries

China

Contacts

Public ContactXue Qian

Shijiazhuang People's Hospital

904555@qq.com+86 311 80915877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026