RecruitingPhase 4NCT06467513

To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

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


Sponsor

Zhang XIao Mei

Enrollment

102 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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.

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Interventions

DRUGEsketamine 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(1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

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NCT06467513


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