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To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

Recruiting
18 - 75 years of age
Both
Phase 4

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Overview

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.

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.

Study details

Heart Diseases, Heart Valve Diseases

NCT06467513

Zhang XIao Mei

25 June 2024

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