Pharmacokinetics
Conditions
Keywords
Sugammadex, renal transplantation
Brief summary
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of rocuronium-induced moderate neuromuscular blockade in patients during renal transplantation
Detailed description
34 patients undergoing renal transplantation or elective surgery are divided into 2 groups, including transplantation group (S group,n=17) and control group (C group, n=17). Patients age 18 to 65 and ASA glass I-III Anaesthesia is induced and maintained with i.v. propofol and an opioid. Neuromuscular monitoring was performed at the adductor pollicis muscle with acceleromyography (TOF-Watch®SX, Organon Ireland Ltd, a division of Merck and Co., Dublin, Ireland). After calibration of the TOF-Watch®SX, an i.v. bolus dose of rocuronium 0.6 mg/kg is given for tracheal intubation, with maintenance doses 0.15mg/kg if T2 reappears to maintain moderate NMB Patients receive sugammadex 2 mg/kg i.v. for reversal when surgery finish and T2 reappears. Venous blood samples of C group(within 12hours) and S group(within 48hours) are obtained before administration of Sug and at specified time points after administration of Sug to determine plasma concentration using HPLC-MS. Time from start of administration of Sug to recovery of TOF ratio to 0.7, 0.8, 0.9 and other clinical indicators are also recorded.
Interventions
DRUGSugammadex
Each patient received a single dose administration of sugammadex 2mg/kg at reappearance of the second twitch of the train-of-four (TOF).
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou General Hospital of Guangzhou Military Command
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergo emergency renal transplantation under general anesthesia(CLCR≤30ml/min),or patients undergo elective surgery in supine position(CLCR≥80ml/min) 2. Patients age 18 to 65 3. ASA glass I-III
Exclusion criteria
1. patients suffering obstructive sleep apnea hypopnea syndrome or BMI≥28kg/m2 2. Pregnant or lactating women 3. neuromuscular disorders, hepatic dysfunction, cardiac disease, a history of malignant hyperthermia, or 4. allergic history during general anesthesia 5. patients receiving aminoglycoside antibiotics, anticonvulsants, magnesium,fusidic acid,toremifene and/or flucloxacillin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Sugammadex | Samples were obtained pre-dose and at specified post-dose time points. C group: up to 12 hours post-dose, S group: up to 48 hours post-dose | venous blood samples were obtained |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time and TOF ratio | up to 10 minutes from start of sugammadex | Time from start of administration of sugammadex to recovery of the T4/T1 Ratio to 0.7 、0.8、0.9 |
| Adverse Event | Up to 2 days | Percentage of Participants With ≥1 Adverse Event |
Countries
China
Contacts
Primary ContactBo Xu
Outcome results
None listed