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Clinical research on esketamine for improving postoperative sleep quality in heart valve surgery patients

Clinical research on esketamine for improving postoperative sleep quality in heart valve surgery patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119211
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

None

Interventions

The low-dose esketamine group (ED group):During the operation, 2.5 mg/ml low-dose esketamine (0.15 mg·kg-1·h-1) was pumped at a rate of 0.06 ml·kg-1·h-1 until the end of the surgery.
The medium-dose esketamine group (Group E):During the operation, 5 mg/ml of the medium-dose esketamine (0.3 mg·kg-1·h-1) was pumped at a rate of 0.06 ml·kg-1·h-1 until the end of the surgery.
Sodium chloride solution group (Group C):During the operation, normal saline was pumped at a rate of 0.06 ml·kg-1·h-1 until the end of the operation.

Sponsors

Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 45 - 75 years old; 2. BMI: 18 - 28 kg/m^2; 3. ASA classification: Grade II - III; NYHA classification: Grade I - III; EF >= 45%; 4. Scheduled for valve replacement surgery under cardiopulmonary bypass.

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone a second heart surgery; 2. Patients with a PSQI score greater than 6 and a MMSE score less than 24 (illiterate < 17, primary school education < 20, junior high school or above < 24) who had sleep disorders and cognitive dysfunction before the surgery; 3. Patients who took sleep aid and melatonin-like drugs before the surgery; 4. Patients with previous neurological or mental disorders, drug abuse, or taking psychotropic drugs; 5. Patients with significantly elevated infection indicators before the surgery; 6. Patients who cannot communicate normally; 7. Patients with severe liver or kidney dysfunction, or severe respiratory diseases; 8. Patients with contraindications for using esketamine; 9. Patients who refused to participate in the study.

Design outcomes

Secondary

MeasureTime frame
Postoperative cognitive function;Postoperative delirium;Postoperative anxiety;Postoperative pain;

Primary

MeasureTime frame
Postoperative sleep;Postoperative sleep rhythm;

Countries

China

Contacts

Public ContactShi Hongwei

Nanjing Medical University Affiliated Nanjing Hospital (Nanjing City First Hospital)

mdshw@163.com+86 189 5167 0892

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026