Clinical trial NCT06608030: Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery
Official title: Effect of a Single Dose of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Cardiac Surgery
S-ketamine
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: The Sixth Medical Center of Chinese PLA General Hospital
First posted: 2024-09-23
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 \&lt;24, or a speech disorder that may compromise their ability to undergo preoperative assessments
3. History of psychoactive drug abuse

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

Primary outcomes:
measure: Perioperative anxiety and depreession
timeFrame: Preoperative day 1, postoperative day 7 and day 30
Secondary outcomes:
measure: Postoperative Sleep Quality
timeFrame: Preoperative day 1, postoperative day 7 and day 30
measure: Delirium
timeFrame: Within 7 days after surgery
measure: PONV
timeFrame: Within 2 days after extubation
measure: Postoperative Recovery Quality
timeFrame: Postoperative day 7 and day 30
measure: Postoperative Pain
timeFrame: Postoperative day 7 and day 30
measure: Postoperative Quality of Life
timeFrame: Postoperative day 7 and day 30
Other outcomes:
measure: Intraoperative blood pressure
timeFrame: During the surgery
measure: Intraoperatively heart rate
timeFrame: During the surgery
measure: Perioperative inflammatory factor (IL-6)
timeFrame: perioperatively
measure: Perioperative inflammatory factor (CRP)
timeFrame: perioperatively
measure: Perioperative brain injury-related factor (S100β)
timeFrame: perioperatively
measure: Perioperative brain-derived neurotrophic factor (BDNF)
timeFrame: perioperatively
measure: Perioperative acetylcholine (Ach)
timeFrame: perioperatively
measure: Perioperative norepinephrine (NE)
timeFrame: perioperatively
Locations:
city: Beijing
country: China
facility: First Medical center of Chinese PLA General Hospital
state: Beijing
city: Bejing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: