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Study on the Safety and Efficacy of Oliceridine for Postoperative Analgesia After Coronary Artery Bypass Grafting

Study on the Safety and Efficacy of Oliceridine for Postoperative Analgesia After Coronary Artery Bypass Grafting

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101324
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

cardiopathy

Interventions

The Oliceridine Group:Configuration method of the analgesic pump: 27 mg of oliceridine, 5 mg of tropisetron and normal saline are mixed to make up to 108 mL (0.25 mg/mL). Parameters of the analgesic p
The Sufentanil Group:100 µg of sufentanil, 5 mg of tropisetron and normal saline are mixed to make up to 100 mL (1 µg/mL). Parameters of the analgesic pump: The initial loading dose is 5 mL (5 µg), th

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective simple coronary artery bypass graft (CABG) surgery under general anesthesia and cardiopulmonary bypass. 2.American Society of Anesthesiologists (ASA) physical status classification: Grade ? to ?. 3.Age ranging from 18 to 75 years old. 4.Body mass index (BMI) between 18 and 27 kg/m².

Exclusion criteria

Exclusion criteria: 1. Sleep apnea syndrome 2.Myocardial infarction within the most recent 28 days 3.Left ventricular ejection fraction less than 45% 4.Use of positive inotropic drugs or mechanical assist devices to assist circulation before surgery 5. Severe liver function abnormalities (bilirubin > 20 mmol/L, international normalized ratio (INR) > 2.0) 6.Chronic kidney disease at stage 4 or 5 (glomerular filtration rate < 30 mL/min/1.73 m²) 7.History of cerebrovascular accident 8.History of Chronic Obstructive Pulmonary Disease (COPD) 9.History of surgery on vital organs (liver, kidney, brain, lung and heart) 10.History of cancer 11.Chronic autoimmune diseases

Design outcomes

Primary

MeasureTime frame
Opioid-induced respiratory depression,OIRD;

Secondary

MeasureTime frame
Area under the curve;

Countries

China

Contacts

Public ContactChen Linlin

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital

lucent777@sina.com+86 135 3814 8270

Outcome results

None listed

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