Reversal of Neuromuscular Blockade
Conditions
Interventions
Group 1:Adamgammadex Sodium 4mg/kg
Group 2:Bridion 2mg/kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) To be volunteered to participate in the clinical study; I or the legal guardian fully understand and know the study and sign the informed consent; willing to follow and complete all test procedures; (2) 18 years old = 18 kg / m2, and the body weight is more than or equal to 50 kg for men and 45 kg for women.
Exclusion criteria
Exclusion criteria: (1) Emergency surgery patients; (2) Known or expected anatomical malformations that make intubation difficult; (3) Known or suspected neuromuscular diseases affecting neuromuscular transmission; (4) Known history of nervous and psychiatric system: craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysms, cerebral vessels; Patients with known history of accident; history of schizophrenia, mania, insanity, long-term use of psychotropic drugs, cognitive dysfunction, etc; (5) Known history of respiratory system: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat tumor, (Branch) tracheoesophageal fistula or airway tear history, acute attack of asthma, and severe respiratory tract infection within 2 weeks before screening; (6) The patients with abnormal blood pressure (systolic blood pressure > 140 mmHg or 90 mmHg or 430 MS, female > 450 ms, and the heart rate 100 BPM, which is judged by the researcher, has clinical significance; (8) Liver dysfunction or previously known liver disease: a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times of the upper limit of normal value; b) Previously known liver diseases, such as acute hepatitis, chronic active hepatitis (HBsAg positive, anti HCV positive), liver cirrhosis, etc.; (9) Renal insufficiency or previously known severe kidney disease: a) Serum creatinine clearance rate (calculated by Cockcroft Gault formula) was less than 60 ml / min; (10) There is a history of hereditary bleeding or coagulation disease or non-invasive haemorrhagic disease (bleeding requiring treatment), a history of thromboembolism, and any disease that can cause bleeding risk (including coagulation disease, thrombocytopenia [platelet count 1.5); (11) Subjects with known or suspected history of malignant hyperthermia or family history; febrile diseases within 7 days before administration; human immunodeficiency virus (HIV) infection (HIV antibody positive); (12) Any known cause of systemic anaphylaxis; known or suspected to be allergic to cyclodextrin, anaesthetic, muscle relaxant and other drugs used in general anesthesia; known to be sensitive to gel electrodes; (13) Those who took fusidic acid and / or toremifene citrate within 24 hours before administration or within 24 hours after expected administration; (14) Within 24 hours before administration or during the operation, it is necessary to receive drugs known to interfere with muscle relaxant Administration [such as antispasmodic drugs, aminoglycoside antibiotics, magnesium salts (except supplement for maintaining physiological level)]; (15) Suspected alcoholics or drug users; (16) Participated in other intervention clinical trials within 3 months before administration; (17) Women who have been pregnant, are preparing for pregnancy during the trial, or are breastfeeding; (18) Women of childbearing age and fertile men w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time from the infection of Adamgammadex Sodium or Bridion to TOFr recovery to 0.9; | — |
Secondary
| Measure | Time frame |
|---|---|
| the time from administration to TOFr recovery to 0.8;the time from administration to TOFr recovery to 0.7;The success rate of the time from administration to TOFr recovery to 0.9 within 5 min;The time from the infection of Adamgammadex Sodium or Bridion to TOFr correction value recovery to 0.9;Proportion of subjects with Recurarization after administration of study drug; | — |
Countries
china
Contacts
Public ContactJin Liu
Outcome results
None listed