Reversal of Neuromuscular Blockade
Conditions
Interventions
Stage 2-Group 1:Stage 2-Group 1
Stage 2-Group 2:Stage 2-Group 2
Stage 2-Group 3:Stage 2-Group 3
Stage 2-Group 4: Stage 2-Group 4
Sponsors
shanghai jiaotong Univercity School of Medicine, Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 64 years old men and women; (2) The American Society of anesthesiologists (ASA) was classified as 1-2; (3) Patients undergoing surgery under general anesthesia and using rocuronium to maintain muscle relaxation; (4) The body mass index (BMI) 18-30 kg / m2 (including the lower limit), and the body weight is more than or equal to 50 kg for men and 45 kg for women; (5) Volunteer 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;
Exclusion criteria
Exclusion criteria: (1) Known or expected anatomical malformations that make intubation difficult; (2) Known or suspected neuromuscular diseases affecting neuromuscular transmission; (3) Patients with obvious liver or kidney dysfunction: -If ALT or AST is more than 1.5 times of the upper limit of normal value or the liver diseases previously known, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; -Serum creatinine (CR) is higher than the upper limit of normal value or a serious kidney disease previously known. (4) Subjects who are known or suspected to have the following conditions: malignant hyperthermia or family history; febrile diseases within 7 days before administration; (5) 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; (6) Within 10 days before the administration, the subjects had taken antibiotics with steroidal structure such as fludicyclic acid, endocrine drugs such as progesterone, norethisterone, testosterone, prednisone, hydrocortisone, etc.; within 3 months before the administration, they had taken endocrine drugs such as toremifene citrate, tamoxifene citrate, clomifene citrate, betamethasone, etc; (7) Drugs (such as antispasmodics, aminoglycosides, magnesium [Mg2 +] and magnesium containing preparations) that are known to interfere with the administration of muscle relaxants are needed in the trial; (8) Participated in other intervention clinical trials within 3 months before administration; (9) Women who have been pregnant, are preparing for pregnancy during the trial, or are breastfeeding.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; (10) Other conditions that the researchers think are not suitable for the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from the administration of adamgammadex sodium or positive drug to the recovery of tofr value to 0.9; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time from the administration of adamgammadex sodium or positive drug to the recovery of tofr value to 0.8;The time from the administration of adamgammadex sodium or positive drug to the recovery of tofr value to 0.7; | — |
Countries
China
Contacts
Public ContactWeifeng Yu
Shanghai Jiaotong Univercity School of Medicine, Renji Hospital
Outcome results
None listed