Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Cardiac Surgery; S-ketamine; Depression, Anxiety

Treatments: Drug: normal saline; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06608030

PLAGH-RCT-Esket

Details and patient eligibility

About

A multicenter, randomized controlled, blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.

Full description

Undergoing surgery can be a traumatic and painful experience for patients, often causing negative moods such as anxiety and depression. The size and type of surgery significantly impact the occurrence of anxiety and depression in patients. Approximately one-third of patients after cardiac surgery experience anxiety or depression, which increases the risk of recurrent cardiovascular events and death.

Ketamine is an anesthetic drug with comprehensive effects, including analgesia, sedation, and amnesia. Its primary mechanism of action is blocking N-methyl-D-aspartate (NMDA) receptors. Esketamine, the pure dextro isomer of ketamine, has a higher affinity for glutamate NMDA receptors and opioid receptors, offering stronger sedative, analgesic, and antidepressant effects. On March 4, 2019, esketamine was approved by the FDA for treatment-resistant depression. Given its analgesic, anesthetic, and antidepressant effects, esketamine may be an ideal drug for improving negative moods in patients undergoing cardiac surgery.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old, male or female
2. Patients undergoing heart valve surgery
3. Patients with ASA grade 1 to 4
4. BMI between 18-30 kg/m²
5. Able to participate in neuropsychological testing and receive follow-up visits
6. Clearly understand and voluntarily agree to participate in the study and sign the informed consent form

Exclusion criteria

1. Patients with significant preoperative neuro-psychiatric disease and cognitive impairment

2. Intellectual disability or a MiniMental State Examination (MMSE) score <24, or a speech disorder that may compromise their ability to undergo preoperative assessments

3. History of psychoactive drug abuse

4. Preoperative combined severe hepatic insufficiency or renal insufficiency 6. Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups, including a placebo group

Esketamine group

Experimental group

Description:

Patients who undergo general anesthesia using esketamine.

Treatment:

Drug: Esketamine

Control group

Placebo Comparator group

Description:

Patients who undergo general anesthesia without esketamine

Treatment:

Drug: normal saline