Clinical study on safety and efficacy of remimazolam tosilate combined with remifentanil in mechanically ventilated patients with mild renal insufficiency

Critical Care Medicine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066937

Enrollment

Unknown

Registered

2022-12-21

Start date

2023-01-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

mild renal insufficiency

Interventions

experience group:Remazolam was given, the load was 6mg / kg / h, pumped in for 3min, and the maintenance amount was 0.25-1mg / kg / h

control group:Midazolam was given a load of 0.15 mg / kg / min for 1 min and a maintenance dose of 0.02-0.1 mg / kg / h

Eligibility

Sex/Gender

All

Age

20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 20 years old = Age =75 years old; 2. Apache ? = 15 points and GCS = 12 points; 3. There is a need for sedative and analgesic treatment; 4. BMI is 18 ~ 30kg / m2; 5. Length of stay in ICU > 24h; 6. Mechanical ventilation > 24h; 7.60ml/min< Ccr<90ml/min 8.Sign informed consent.

Exclusion criteria

Exclusion criteria: 4. Craniocerebral trauma, cerebrovascular accident and other central nervous system diseases, neuromuscular joint injury diseases, or taking antidepressants, hypnotics, anxiety drugs or antiepileptic drugs; 5. Patients with a history of alcohol or drug abuse; 6. No need for sedation and analgesia; 7. Receive anesthesia or any form of sedation and analgesia within 24 hours (including regional block and local anesthesia); 8. Patients who are allergic to midazolam, remazolam or remifentanil; 9. Patients with ECG abnormalities or shock such as second or third degree atrioventricular block or any rhythm bradycardia other than sinus rhythm, second / third degree atrioventricular block, QT time extension (corrected QT interval > 450ms); 10. GCS score < 12; 11. Pregnancy or lactation; 12. Inability to obtain informed consent

Design outcomes

Primary

Measure	Time frame
Complete recovery time after stopping medication;	—

Secondary

Measure	Time frame
Time from the beginning of drug infusion to loss of consciousness;Failure rate of sedation;incidence of adverse drug events;Time from the beginning of drug infusion to Rass -2;General basic patient information;Ccr;BUN;Cr;TBIL;DBIL;CK-MB;electrocardiogram;sonography;Bispectral index,BIS;Number of haemodynamic administrations;blood pressure;RASS;breathing rate;heart rate;	—

Countries

China

Contacts

Public ContactYan Wang

Shannxi Provincial People's Hospital

58380555@qq.com13572426908

Outcome results

None listed

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