Investigating esketamine's effects on pulmonary complications during heart surgery
To Investigate the Effect of Esketamine on Hemodynamics and Postoperative Pulmonary Complications in Patients Undergoing Heart Valve Replacement Surgery
This study is testing if giving esketamine during heart valve replacement surgery can help prevent breathing problems after the surgery for patients aged 18 to 75.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zunyi Medical College Academic / other |
| Locations | 1 site (Zunyi, Guizhou) |
| Trial ID | NCT06467513 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of esketamine hydrochloride on intraoperative hemodynamics and postoperative pulmonary complications in patients undergoing heart valve replacement surgery. Eligible participants, aged 18-75, will be randomly assigned to receive either a low or high dose of esketamine or a control solution during surgery. The study employs a double-blind methodology to ensure unbiased results. The primary goal is to determine if esketamine can improve outcomes related to pulmonary complications following heart surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 scheduled for elective mitral or aortic valve replacement surgery requiring extracorporeal circulation.
Not a fit: Patients with existing pulmonary complications or those undergoing non-cardiac surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and reduced pulmonary complications for patients undergoing heart valve surgery.
How similar studies have performed: While the use of esketamine in this context is relatively novel, similar studies have shown promising results in managing intraoperative hemodynamics.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zunyi, Guizhou
- Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
Study contacts
- Principal investigator: Haiying Wang — Director of anesthesiology Department, Affiliated Hospital of Zunyi Medical University
- Study coordinator: Xiaomei Zhang
- Email: 3233598996@qq.com
- Phone: +0086 18786233321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.