Reversal of Neuromuscular Blockade
Conditions
Interventions
Stage 1-Group 1:0.9% NaCl
Stage 1-Group 2:Adamgammadex Sodium
Stage 2-Group 1:Adamgammadex Sodium 4mg/kg
Stage 2-Group 2:Adamgammadex Sodium 6mg/kg
Stage 2-Group 3:Bridion 2mg/kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 64 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 <= age <= 64 years old, unlimited for men and women; (3) The American Society of anesthesiologists (ASA) was classified as 1-2; (4) The subjects must undergo elective surgery under general anesthesia according to plan, and need to use muscle relaxant rocuronium to complete endotracheal intubation and maintain muscle relaxation, and pull out endotracheal catheter after operation; (5) The body mass index (BMI) is less than 30 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) Known or expected anatomical malformations that make intubation difficult; (2) Known or suspected neuromuscular diseases affecting neuromuscular transmission; (3) 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; (5) Patients with obvious liver or kidney dysfunction: -ALT or ast > 2.0 times of the upper limit of normal value or previously known liver diseases, such as acute hepatitis, chronic active hepatitis (hepatitis B surface antigen positive, hepatitis C antibody positive), cirrhosis, etc; -Serum creatinine (CR) is higher than the upper limit of normal value or a serious kidney disease previously known. (6) 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); (7) 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); (8) 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; (9) Within 10 days before administration, the subjects took antibiotics with steroidal structure such as fusidic acid, endocrine drugs such as progesterone, norethisterone, testosterone, prednisone, hydrocortisone, etc.; within 3 months before administration, they took endocrine drugs such as toremifene citrate, tamoxifene citrate, clomifene citrate, betamethasone, etc; (10) Drugs known to interfere with the administration of muscle relaxants (such as antispasmodic drugs, aminoglycoside antibiotics, magnesium [Mg2 +]) need to be accepted in the trial; (11) Participated in other intervention clinical trials within 3 months before administration; (12) Women who have been pregnant, are preparing for pregnancy during the trial, or are breastfeeding; (13) During the study period and within one month after the end of the study, women of childbearing age and fertile men were unwilling or unable to use reliable contraceptive methods; (14) Personnel involved in the research plan and implementation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time from the infection of Adamgammadex Sodium or Bridion to TOFr recovery to 0.9;Safety assessment;Pharmacokinetic index; | — |
Secondary
| Measure | Time frame |
|---|---|
| the time from administration to TOFr recovery to 0.8;the time from administration to TOFr recovery to 0.7; | — |
Countries
China
Contacts
Public ContactJin Liu Yingying Jiang
West China Hospital, Sichuan University
Outcome results
None listed