Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery
NCT ID: NCT06608030
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
142 participants
INTERVENTIONAL
2024-09-24
2025-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Esketamine group
Patients who undergo general anesthesia using esketamine.
Esketamine
A single dose of 0.3mg / kg esketamine during induction of anesthesia.
Control group
Patients who undergo general anesthesia without esketamine
normal saline
Receiving the same volume of normal saline during induction of anesthesia.
Interventions
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Esketamine
A single dose of 0.3mg / kg esketamine during induction of anesthesia.
normal saline
Receiving the same volume of normal saline during induction of anesthesia.
Eligibility Criteria
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Inclusion Criteria
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
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
5\. Preoperative combined severe hepatic insufficiency or renal insufficiency 6. Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
The Sixth Medical Center of Chinese PLA General Hospital
UNKNOWN
Chinese PLA General Hospital
OTHER
Responsible Party
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Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Locations
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First Medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Weidong Mi, PhD
Role: primary
Zhuoning Zhang
Role: backup
Yishuang Wu
Role: primary
Other Identifiers
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PLAGH-RCT-Esket
Identifier Type: -
Identifier Source: org_study_id