Clinical trial NCT06467513: To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
Official title: To Investigate the Effect of Esketamine on Hemodynamics and Postoperative Pulmonary Complications in Patients Undergoing Heart Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Heart Diseases
Heart Valve Diseases
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study was divided into 3 groups, one group was placebo group, the other group was low-dose esketamine group (continuous injection of esketamine until the end of surgery), the dose was 0.2mg/kg; The other group was the Esketamine high-dose group (the continuous injection of esketamine during the operation until the end of the operation) with a dose of 0.4mg/kg.
Primary purpose: OTHER

Brief summary: The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications

Detailed description: After being informed of the study and potential risks, all patients who gave written informed consent will undergo pre-operative screening to determine eligibility for study enrollment. Before operation, eligible patients were randomly divided into esketamine group (0.2mg/kg, intraoperative pump), esketamine group (0.4mg/kg, intraoperative pump) and blank control group (physiological salt pump) in a double-blind way at a ratio of 1:1:1.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old, gender unlimited.
* Elective heart surgery.
* Patients who plan to undergo mitral and (or) aortic valve replacement (or repair) surgery, requiring extracorporeal circulation and aortic occlusion.
* The New York Heart Association class is less than 4.
* Voluntarily sign informed consent.

Exclusion Criteria:

* Non-cardiac surgery.
* Second heart surgery.
* Interventional surgery in heart valve surgery (TAVI, mitral clamp).
* The patient refuses.
* Pregnant women.
* Patients with a history of lung surgery.
* Patients with acute kidney injury requiring dialysis.
* Patients with chronic renal insufficiency (stage III and above).
* The patient was intubated before arriving at the operating room.
* Patients with existing pulmonary complications (respiratory tract infection, pneumonia, pleural effusion, respiratory failure, atelectasis, pneumothorax, bronchospasm, ARDS).
* The patient had neuropsychiatric disease and cognitive impairment before surgery.
* Drug users and other long-term use of antipsychotic drugs.
* Patients with any of the following contraindications for the use of ESketamine injection: patients with serious risk of elevated blood pressure or intracranial pressure; Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic pressure exceeding 180 mmHg, or resting diastolic pressure exceeding 100mmHg); Patients with untreated or undertreated hyperthyroidism (hyperthyroidism).
* Liver function ALT, AST \> 2 times normal.

Primary outcomes:
measure: Pulmonary ultrasound score
timeFrame: Baseline and day 1, day 2 and day 3 after surgery
Secondary outcomes:
measure: The concentration of interleukin 6
timeFrame: At baseline, before anesthesia induction, 10 minutes after insertion of tracheal catheter, 10 minutes after cardiopulmonary bypass, 10 minutes after completion of cardiopulmonary bypass, at the end of surgery, and 1 day after completion of surgery.
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
affiliation: Staff member of Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
name: Wei Chen
role: STUDY_DIRECTOR
affiliation: Director of anesthesiology Department, Affiliated Hospital of Zunyi Medical University
name: Haiying Wang
role: PRINCIPAL_INVESTIGATOR
References: