A Double-blind, Randomized, Parallel Design Study to Compare Postoperative Recovery Between the Sugammadex Group and the Neostigmine Group in Patients After COVID-19.

2023AS0079

Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery, with a focus on the occurrence of postoperative urinary dysfunction, in patients who have undergone regular abdominal surgery within a year of being infected with and treated for COVID-19. Post COVID-19 condition is a new and poorly understood clinical syndrome with potentially significant and life-altering consequences. Recent studies suggest that patients who have recovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomic dysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscular blockers are used, and their residual effects delay the recovery of autonomic function after surgery, leading to problems such as worsening bladder and bowel function. Therefore, reversal agents are used to aid in postoperative muscle recovery, with sugammadex and neostigmine being commonly used in clinical practice. While sugammadex is generally expected to result in faster postoperative recovery, limited reports exist on its effectiveness in patients who have recovered from COVID-19. This study aims to verify whether sugammadex is more effective than neostigmine in aiding the recovery of bowel and pulmonary function after surgery in patients who have recovered from COVID-19.

2023-04-20

2024-12-25

2024-12-31

Not yet recruiting

Early phase I

300

Inclusion Criteria: * Ages between 19 and 70 Male and Female All ethnicity Patients who are scheduled to take non-emergency abdominal surgery under general anesthesia. Patients who had the diagnosis of covid-19 by PCR, hospitalized, and applied O2 supplement therapy. ASA classification ≤ 3 Patients who had Covid-19 PCR positive within 1 year Patients who had hospitalized by Covid-19, followed by O2 therapy (nasal prong, continuous positive airway pressure (CPAP), ventilator etc.) Patients who hospitalized more than 48 hours after surgery. Patients who had a surgery for more than 1 hour. Exclusion Criteria: * Not meeting inclusion criteria Declined to participate Active Covid-19 patients with PCR positive. Patients are under 19 or over 70 years old

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A double-blind, randomized, parallel design study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "The neuromuscular reversal agent is received and prepared in advance by a separate medical staff (a separate anesthesiologist who does not participate in the patient's anesthesia), and the corresponding prescription order is made separately when the patient leaves the recovery room. Since it is diluted with physiological saline and prepared in a total amount of 5cc, the patient and the patient's anesthetist do not know about the drug until they leave the recovery room (double-blinded).", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-04-18