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

NCT06608030 | Completed

• 1 other identifier: PLAGH-RCT-Esket
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression, Anxiety; Cardiac Surgery; S-ketamine

Outcome Measures

Primary Outcomes (1)

• Perioperative anxiety and depreession

  The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.

  Preoperative day 1, postoperative day 7 and day 30

Secondary Outcomes (6)

• Postoperative Sleep Quality

  Preoperative day 1, postoperative day 7 and day 30

• Delirium

  Within 7 days after surgery

• PONV

  Within 2 days after extubation

• Postoperative Recovery Quality

  Postoperative day 7 and day 30

• Postoperative Pain

  Postoperative day 7 and day 30

Other Outcomes (8)

• Intraoperative blood pressure

  During the surgery

• Intraoperatively heart rate

  During the surgery

• Perioperative inflammatory factor (IL-6)

  perioperatively

Study Arms (2)

Esketamine group

EXPERIMENTAL

Patients who undergo general anesthesia using esketamine.

Drug: Esketamine

Control group

PLACEBO COMPARATOR

Patients who undergo general anesthesia without esketamine

Drug: normal saline

Interventions

Esketamine DRUG

A single dose of 0.3mg / kg esketamine during induction of anesthesia.

Esketamine group

normal saline DRUG

Receiving the same volume of normal saline during induction of anesthesia.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with significant preoperative neuro-psychiatric disease and cognitive impairment
• Intellectual disability or a MiniMental State Examination (MMSE) score \<24, or a speech disorder that may compromise their ability to undergo preoperative assessments
• History of psychoactive drug abuse
• \. Preoperative combined severe hepatic insufficiency or renal insufficiency 6. Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator
• The Sixth Medical Center of Chinese PLA General Hospital: collaborator

Study Sites (2)

First Medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China, China

Location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Zhang ZN, Hao XY, Cai C, Sun L, Zhang ZY, Wang M, Wu YS, Wang Y, Cao JB, Liu YH, Lou JS, Fu Q, Jiang SL, Han RQ, Mi WD, Tong L. Effect of esketamine on postoperative depression and anxiety in patients undergoing cardiac valve surgery: A randomised, placebo-controlled, double-blinded clinical trial. Pharmacol Res. 2025 Dec;222:108047. doi: 10.1016/j.phrs.2025.108047. Epub 2025 Nov 22.

  PMID: 41285329 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 23, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)