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A multicenter prospective randomized controlled study of remimazolam besylate for sedation in patients on mechanical ventilation after cardiac surgery

A multicenter prospective randomized controlled study of remimazolam besylate for sedation in patients on mechanical ventilation after cardiac surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075015
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Cardiac surgery

Interventions

Trial Group:Remazolam benzosulfonate was used for postoperative sedation
Control group:Postoperative sedation using midazolam

Sponsors

Cardiothoracic surgery ICU of the First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with cardiopulmonary bypass in cardiac surgery who return to ICU after surgery and need to receive tracheal intubation mechanical ventilation (2) Age =18 and =75 years old, gender is not limited (3) Body mass index =18 and =28kg/m2 (4) Patients or family members have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign informed consent

Exclusion criteria

Exclusion criteria: (1) Off-pump heart surgery (2) Patients involved in hypothermia during the operation (3) Patients with heart or cardiopulmonary transplantation (4) History or evidence of increased risk of sedation: cardiovascular system (bradycardia requiring medication and/or heart rate =50 beats/min, History of severe arrhythmias such as grade II-III atrioventricular block,Patients with systolic blood pressure =90mmHg when using high doses of vasoactive drugs), Patients with mental system diseases (such as schizophrenia, depression, etc.) and cognitive dysfunction, with a history of abuse of psychotropic drugs and narcotic drugs, long-term use of psychotropic drugs, etc. (5) Patients with severe renal insufficiency or end-stage renal disease (creatinine clearance less than 30ml/min or glomerular filtration rate less than 30ml/min/1.73m2) or dialysis patients (6) Patients with moderate to severe hepatic insufficiency (child-pugh grade B and C) (7) Pregnant and lactating women (8) Allergic to benzodiazepines (9) Participants in other clinical trials within 30 days (10) Incomplete information (11) The investigator judges that it is not possible to complete or not appropriate to participate in the researcher (death is expected within 72 hours, and active treatment is refused).

Design outcomes

Primary

MeasureTime frame
Mechanical ventilation time;

Secondary

MeasureTime frame
Inflammatory response indicators;Stress response indicators;Hemodynamic indicators;complication;

Countries

China

Contacts

Public ContactWang Cuiping

The First Affiliated Hospital of Sun Yat-Sen University

14316310@qq.com+86 134 3025 9156

Outcome results

None listed

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