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Not Yet Recruiting NCT05721144

Inhaled NO in Surgical Patients With Recent COVID-19 Infection

Conditions: Nitric Oxide, COVID-19, Surgery, Postoperative Complications

Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 660
Sponsor: Xijing Hospital

Summary

The aim of this study is to evaluate the effect of perioperative inhalation of NO on reducing the incidence of postoperative pulmonary complications in patients with recent COVID-19 infection, and to evaluate whether inhaled NO can improve the prognosis of patients.The investigators will enroll 660 surgical patients who was infected with SARS-CoV-2 within 42days (7 weeks ) prior to planed surgery under general anesthesia. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or a placebo. Perioperative standards of care will be the institution's own protocols (such as ventilation strategies and use and dose of anesthetics, analgesia and fluid management, etc).

Eligibility Criteria

Inclusion Criteria:≥ 18 years oldPlanned for surgery under general anesthesiaWith a history of COVID-19 infection within 7 weeks prior to surgery.Exclusion Criteria:Physician makes a decision that trial involvement is not in the patient's best interest or any condition that does not allow the protocol to be followed safelyASA ≥ IV, life expectancy< 24 h.Pregnant or lactating women.Severe liver disease (Child-Pugh score ≥ 12).Patients with severe respiratory failure need mechanical ventilation support or ECMO life support before the operation.Severe renal dysfunction (eGFRC≤30 ml/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, and peritoneal dialysis.Having received or participated in other clinical trials within the previous month.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05721144). StuddyBuddy aggregates publicly available trial information.