To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

Heart Diseases Clinical Trial

Official title:

To Investigate the Effect of Esketamine on Hemodynamics and Postoperative Pulmonary Complications in Patients Undergoing Heart Valve Replacement Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467513
• Other study ID #: KLL-2023-223
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Zunyi Medical College
• Contact: Xiaomei Zhang
• Phone: +0086 18786233321
• Email: 3233598996[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases

Intervention

Drug:
• Esketamine hydrochloride injection
The low dose esketamine hydrochloride group was given 0.2mg/kg at induction of anesthesia, the high dose esketamine hydrochloride group was given 0.4mg/kg at induction of anesthesia, and the blank control group was not given Esketamine hydrochloride injection at induction of anesthesia.

Locations

Country	Name	City	State
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhang XIao Mei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary ultrasound score	The anterior axillary line, posterior axillary line and paraspinal line were used as the boundary, and each lung was divided into 3 regions: anterior chest, underarm and back. Each area was given a maximum score of 3 out of 36, with higher scores indicating worse lung condition.	Baseline and day 1, day 2 and day 3 after surgery
Secondary	The concentration of interleukin 6	The concentration of interleukin-6 in participants before and during surgery, as well as after surgery, can reflect the size of the inflammatory response to some extent.	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.