To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

Zhang XIao Mei

Status and phase: Enrolling; Phase 4

Conditions: Heart Valve Diseases; Heart Diseases

Treatments: Drug: Esketamine hydrochloride injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06467513

KLL-2023-223

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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102 participants in 3 patient groups

blank control group

No Intervention group

Description:

In the blank control group, no intervention was used during the operation, and normal saline was pumped according to the participant's body weight until the end of the operation.

Low dose esketamine hydrochloride injection group

Experimental group

Description:

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.

Treatment:

Drug: Esketamine hydrochloride injection

High dose esketamine hydrochloride injection group

Experimental group

Description:

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.

Treatment:

Drug: Esketamine hydrochloride injection