NCT06467513 To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
| NCT ID | NCT06467513 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zhang XIao Mei |
| Condition | Heart Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 102 participants in total. It began in 2024-01-01 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Wei Chen
STUDY DIRECTOR
Staff member of Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
Frequently Asked Questions
Who can join the NCT06467513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Heart Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06467513 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06467513 currently recruiting?
Yes, NCT06467513 is actively recruiting participants. Contact the research team at 3233598996@qq.com for enrollment information.
Where is the NCT06467513 trial being conducted?
This trial is being conducted at Zunyi, China.
Who is sponsoring the NCT06467513 clinical trial?
NCT06467513 is sponsored by Zhang XIao Mei. The principal investigator is Wei Chen at Staff member of Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University. The trial plans to enroll 102 participants.