Postoperative pulmonary complications
Conditions
Interventions
Sugammadex Group:After the surgery, when T2 reappears, administer 2 mg/kg of sugammadex.
Non-Sugammadex Group:Postoperatively, administer neostigmine antagonism at the conventional dose (0.02-0.04 mg/kg, with a maximum dose of 5 mg), or no antagonistic drug usage, both of which are includ
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age>=65 years, <=80 years; 2) patients with rocuronium bromide or vecuronium bromide to induce neuromuscular block during general anesthesia surgery; 3) American Society of Anesthesiologists (ASA) physical condition classification I~III; 4) Patients undergoing elective non-cardiac major surgery (operation time greater than 2 hours).
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to sugammadex sodium, neostigmine, rocuronium, vecuronium bromide and other anesthetics; 2) Known history of respiratory system: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of (bronchoesophageal fistula) or airway tear, acute exacerbation of asthma, severe respiratory infection within nearly 2 weeks prior to screening; 3) Known heart failure or other serious cardiovascular disease; New York Heart Association grade III or above; ECG abnormality, QTc interval (corrected with Fridericia) male>430ms, Female> 450 ms and clinically significant as judged by the investigator; Heart rate 100bpm and clinically significant as judged by the investigator; 4) Known history of neurological and psychiatric system: head injury, possible convulsions, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; History of schizophrenia, mania, mental disorder, long-term use of psychotropic drugs, cognitive dysfunction, etc.; 5) Hepatic insufficiency or pre-known liver disease: a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal; 6) Renal insufficiency or previously known severe kidney disease: a) Serum creatinine clearance (calculated by Cockcroft-Gault formula) < 60 mL/min; 7) Patients undergoing thoracic surgery: lung, esophageal and other thoracic surgery; 8) Within 3 months prior to dosing and/or planned to participate in other interventional clinical trials during the study. In the opinion of the investigator, it is not suitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative pulmonary complications during hospitalization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from administration to recovery of TOFR to 0.9;Success rate of antagonism within 5 minutes of administration, with TOFR recovery to 0.9;Time from administration to extubation;PACU (Post-Anesthesia Care Unit) stay duration;Reappearance rate of neuromuscular blockade after administration during PACU stay;Postoperative incision pain score at 3 days;Postoperative 3-day sleep NRS score;Postoperative 3-day incidence of gastrointestinal dysfunction;Anxiety and depression scores (HADS score);Postoperative 30-day complication rate;Incidence of delirium within 3 days postoperatively;Length of hospital stay;Number of readmissions within 30 days;Incidence of adverse events in the PACU;Incidence of nausea and vomiting within 3 days postoperatively;Incidence of bradycardia and tachycardia within 2 hours postoperatively;Incidence of hypertension and hypotension within 2 hours postoperatively;Incidence of airway complications within 3 days postoperatively (including upper airway obstruction, laryngospasm, and bronchospasm);Incidence of neurological disorders within 24 hours postoperatively (including headache, dizziness, and sensory impairment);Incidence of musculoskeletal and connective tissue disorders within 24 hours postoperatively: limb pain, musculoskeletal pain, and myalgia;Incidence of agitation within 3 days postoperatively;Incidence of allergic reactions within 24 hours postoperatively;Number of patients requiring unplanned reintubation during hospitalization;Number of patients requiring mechanical ventilation for more than 48 hours; | — |
Countries
China
Contacts
Public ContactXiaoping Gu
Nanjing Drum Tower Hospital
Outcome results
None listed