Reversal of Neuromuscular Blockade
Conditions
Interventions
Experiment Group:Adamgammadex 8mg/kg
Control Group:Sugammadex 4mg/kg
Sponsors
Shanghai Jiaotong Univercity School of Medicine, Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.The patients should be willing to participate in the clinical study; the patients or their legal guardian should fully understand and know this study and sign an informed consent; the patients should be willing to follow and be able to complete all test procedures; 2.Aged between 18 and 64 years, no gender limitation; 3.The grade of American Society of Anesthesiologists (ASA) was grade 1-3; 4.The subjects must undergo the selective operation under general anesthesia as planned, and need to use the muscle relaxant rocuronium bromide to complete the endotracheal intubation and maintain muscular relaxation; 5. Body mass index (BMI) 18 - 30 kg/m2, and weight >= 50 kg for males and >= 45 kg for females.
Exclusion criteria
Exclusion criteria: 1.Emergency surgery patients; 2.Known or expected anatomical deformities that cause difficulty in intubation; 3.Known or suspected neuromuscular diseases affecting neuromuscular transmission; 4.Known history of nervous and mental system: brain injury, possible convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, schizophrenia, mania, insanity, long-term use of psychotropic drugs, cognitive impairment, etc., which are not suitable for inclusion in the study after the evaluation of the researcher; 5.Known history of respiratory system: severe chronic obstructive pulmonary disease, acute attack of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, (Branch) tracheoesophageal fistula or airway tear history, acute attack of asthma, severe respiratory infection in recent 2 weeks before screening, etc., which are not suitable for inclusion in the study after the evaluation of the researcher; 6.Those who have abnormal blood pressure (systolic blood pressure > 140 mmHg or 90 mmHg or 430 ms for males, > 450 ms for females, which is judged to have clinical significance by the investigators; with heart rate 100 bpm, which is judged to have clinical significance by the investigators; 8.Patients with obvious liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal value or having previously known liver diseases, such as acute hepatitis, chronic active hepatitis (positive hepatitis B surface antigen, and positive hepatitis C antibody) and liver cirrhosis; Serum creatinine (Cr) > the upper limit of normal value or having previously known severe kidney diseases. 9.Renal insufficiency or previously known severe renal disease (serum creatinine clearance 1.5); 11.Subjects with known or suspected history of malignant hyperthermia or family history; Febrile disease (>= 37.3 ?) within 7 days before randomization; 12.Human immunodeficiency virus (HIV) infection (positive HIV antibody); 13.Subjects showing systemic allergic reactions caused by any known reasons; subjects known or suspected to be allergic to cyclodextrin, anesthetics, muscle relaxants and other drugs used in general anesthesia; subjects known to be allergic to gel electrodes; 14.Subjects who have taken fusidic acid and /or taken toremifene citrate within 24 hours before drug administration or within 24 hours after expected administration ; 15.In the test, the subjects need to accept drugs that are known to hinder the administration of muscle relaxants (e.g. anticonv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from the administration of adamgammadex sodium or Sugammadex to the recovery of TOFr value to 0.9; | — |
Secondary
| Measure | Time frame |
|---|---|
| TOFr was restored to 0.9 within 5 minutes from the administration of Admgammadex sodium for injection or positive control drug;The time from the administration of adamgammadex sodium or Sugammadex to the recovery of TOFr value to 0.8;The time from the administration of adamgammadex sodium or Sugammadex to the recovery of TOFr value to 0.7;The time from the administration of adamgammadex sodium or Sugammadex to the recovery of TOFr adjust value to 0.9;Proportion of subjects with recurrence of muscle relaxation within 30 minutes after administration of test drug; | — |
Countries
China
Contacts
Public ContactYu Weifeng
Shanghai Jiaotong Univercity School of Medicine, Renji Hospital
Outcome results
None listed