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Efficacy and safety of Ciprofol for sedation in cardiac postoperative patients: A prospective, randomized, controlled study

A clinical study on the efficacy and safety of Ciprofol for sedation in cardiac postoperative patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081043
Enrollment
Unknown
Registered
2024-02-21
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

none

Interventions

Group C:Patients after cardiac surgery were treated with ciprofol combined with remifentanil for sedation and analgesia.The goal of sedation is to maintain the RASS score between -2 and 1, and the goa
Group P:Patients after cardiac surgery were treated with propofol combined with remifentanil for sedation and analgesia.The goal of sedation is to maintain the RASS score between -2 and 1, and the goa

Sponsors

Xuzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing coronary artery bypass grafting (CABG) or/and aortic and/or mitral valve replacement 2.18 years = age = 80 years 3.18 = BMI = 30 kg/m2 4. The patient is aware of this clinical study and has signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Severe heart failure with left ventricular ejection fraction less than 40%, second-degree or third-degree atrioventricular block with heart rate less than 50 beats per minute, or QTc interval greater than or equal to 450 milliseconds. 2.History of cognitive impairment (Alzheimer's disease, Parkinson's disease, etc.) or seizure disorder. 3.Acute hepatitis or severe liver dysfunction (Child-Pugh grade C). 4.Severe renal insufficiency with glomerular filtration rate less than 60 ml/min/1.73m2. 5.Known allergies to eggs, soy products, or investigational drugs (propofol, ciprofol, remifentanil, or midazolam). 6.Mental illness, history of drug abuse, or alcoholism. 7. Other situations determined by the researchers that are not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Percentage of time without additional sedation within the target sedation range;The incidence of safety events, including any of the following events: hypotension (SBP < 90 mmHg for more than 5 minutes), bradycardia (HR < 50 beats/minute for more than 5 minutes), and hypoxemia (SpO2 < 90% for more than 5 minutes). The dosage of vasoactive drugs and positive inotropic drugs.;The recovery quality score measured by the QoR-40 questionnaire on the third day after surgery, and the incidence of delirium (the incidence of delirium 12 and 24 hours after admission to the ICU, assessed using the CAM-ICU scale);Duration of sedation, RAAS score, CPOT score, total dose of analgesics and sedatives;Postoperative organ function (oxygenation index, creatinine, aminotransferase, bilirubin, S100 ß Protein, etc.);

Secondary

MeasureTime frame
Extubation time, ICU hospitalization time, hospital mortality, 28-day mortality;Cardiac-related complications: incidence of myocardial injury, incidence of new-onset atrial fibrillation, incidence of new-onset ischemic electrocardiogram assessed using cTnI;

Countries

China

Contacts

Public ContactGuo Lulu

Xuzhou Central Hospital

1449014898@qq.com+86 157 2287 5758

Outcome results

None listed

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