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Effect of Perioperative Infusion of Esketamine on Postoperative Depressive Symptoms and Neurological Injury in Patients Undergoing Cardiac Surgery: A Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

Effect of Perioperative Infusion of Esketamine on Postoperative Depressive Symptoms and Neurological Injury in Patients Undergoing Cardiac Surgery: A Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129302
Enrollment
Unknown
Registered
2026-08-03
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Depressive symptoms

Interventions

Intervention group (esketamine group):Perioperative administration of esketamine, including loading doses during anesthesia induction and continuous intravenous infusion during surgery.
Control group (normal saline group):All patients were given equal volumes of physiological saline (0.9% NaCl) at the same rate.

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-80 years; 2.Elective off-pump coronary artery bypass grafting under general anesthesia; 3.ASA classification II-IV; 4.Normal preoperative cognitive function (MMSE >= 24 points); 5.Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have been previously diagnosed with severe mental disorders (schizophrenia, bipolar disorder) or major depression and are currently taking medication; . 2. Severe cardiovascular risk: Uncontrolled hypertension (SBP>180 mmHg and/or DBP>110 mmHg), severe left main coronary artery disease (stenosis >50%), severe aortic stenosis, resting heart rate >100 bpm; 3. Neurological contraindications: Intracranial hypertension, intracranial tumors, cerebral vascular malformations, untreated aneurysms, history of epilepsy; 4. Severe liver and kidney dysfunction (Child-Pugh grade C or eGFR <15 mL/min/1.73m^2); 5. A history of severe glaucoma or penetrating eyeball injuries; 6. There is a history of abuse/dependence on ketamine, opioids or psychoactive substances in the past; 7. Allergic to esketamine or any excipients; 8. Emergency surgery, heart transplantation, and deep hypothermic circulatory arrest surgery; 9. Pregnant and lactating women; 10. The researchers determined that there were other conditions where the use of esketamine was not suitable (such as severe untreated hyperthyroidism);

Design outcomes

Primary

MeasureTime frame
Incidence of clinically significant depressive symptoms within 7 days postoperatively;

Secondary

MeasureTime frame
The severity of depression and quality of life;Neuroimmune inflammatory indicators (BDNF, IL-6, TNF-a);Pain indicators;Cognitive function indicators;ICU stay time (h);Total length of hospital stay (d);Intraoperative hemodynamic abnormalities;Postoperative delirium;Mental nomenclature symptoms;

Countries

China

Contacts

Public ContactMiao Changhong

Zhongshan Hospital, Fudan University

miao.changhong@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026