To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

Phase 4

Recruiting

• Conditions: Heart Valve Diseases; Heart Diseases
• Interventions: Drug: Esketamine hydrochloride injection

• Registration Number: NCT06467513
• Lead Sponsor: Zhang XIao Mei

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low dose esketamine hydrochloride injection group	Esketamine hydrochloride injection	In the low-dose ESketamine hydrochloride injection group, 50mg of Esketamine hydrochloride injection was diluted with normal saline into a 50ml syringe, which was wrapped with light-proof paper and pumped continuously from the beginning of anesthesia to the end of surgery. The dosage was calculated as 0.2mg/kg.h.
High dose esketamine hydrochloride injection group	Esketamine hydrochloride injection	In the high-dose ESketamine hydrochloride injection group, 50mg of Esketamine hydrochloride injection was diluted with normal saline into a 50ml syringe, which was wrapped with light-resistant paper and pumped continuously from the beginning of anesthesia to the end of surgery. Dosage was calculated as 0.4mg/kg.h.

Primary Outcome Measures

Name	Time	Method
Pulmonary ultrasound score	Baseline and day 1, day 2 and day 3 after surgery	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.

Secondary Outcome Measures

Name	Time	Method
The concentration of interleukin 6	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.	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.

Trial Locations

Locations (1)

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China