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Efficacy and safety of postoperative analgesia with esketamine for patients with depression after cardiac surgery

Efficacy and safety of postoperative analgesia with esketamine for patients with depression after cardiac surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049288
Enrollment
Unknown
Registered
2021-07-29
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

coronary heart disease

Interventions

Experimental group:esketamine
Control group:normal saline

Sponsors

Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, gender is not limited; 2. Patients undergoing open heart surgery under elective general anesthesia; 3. Body mass index (BMI) >= 19 and <= 30 kg/m^2; 4. ASA is classified as II-III; 5. Non-emergency inpatients who have undergone routine preoperative preparation; 6. Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of valve or coronary artery bypass surgery; 2. Patients with coronary artery bypass surgery, aortic surgery, severe aortic atherosclerosis; 3. Patients with myocardial infarction, severe myocardial ischemia, severe hypertension or other serious heart diseases; 4. Those with bronchial asthma, chronic respiratory diseases or other serious respiratory diseases; 5. Patients with craniocerebral injury, intracranial lesions and elevated intracranial pressure; 6. Complicated with neurological disease, mental illness or intellectual disability, unable to correctly describe their own feelings or unable to understand the VAS score, and will not use PCA; 7. Patients with glaucoma or other elevated intraocular pressure; 8. Preoperative ALT, AST >= 1.5 times the upper limit of normal, or Cr > 1.5 times the upper limit of normal; 9. Acute alcoholism or alcohol dependence; 10. Those who are addicted and resistant to opioids; 11. Long-term use of opioid analgesics, general anesthetics, sedatives, hypnotics or other central nervous system depressants; 12. Allergic constitution or known history of allergy to the drugs specified in this research protocol (esketamine, ketamine, morphine, tropisetron, dexamethasone, midazolam, propofol, sufentanil, cisatracurium, remifentanil, atropine, ephedrine, flurbiprofen axetil, etc.); 13. Those who have participated in other clinical trials within 3 months before screening; 14. Pregnant and lactating patients; 15. In addition to the above, the patients who are judged by the researchers to be unsuitable for participation are patients with pulmonary diseases (asthma, emphysema, chronic obstructive pulmonary disease, etc.).

Design outcomes

Primary

MeasureTime frame
Baker depression inventory score;IL-6;IL-8;TNF-a;C reactive protein;Troponin T;Creatine kinase-isozyme MB;Blood pressure;Heart rate;Hospitalization time;Detention time in ICU;

Secondary

MeasureTime frame
Pain score;Adverse effect;

Countries

China

Contacts

Public ContactSun Lixin

Qingdao Municipal Hospital

sunlixin1221@sina.com+86 15621022955

Outcome results

None listed

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