Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergo emergency renal transplantation under general anesthesia(CLCR≤30ml/min),or patients undergo elective surgery in supine position(CLCR≥80ml/min) Patients age 18 to 65 ASA glass I-III Exclusion Criteria: patients suffering obstructive sleep apnea hypopnea syndrome or BMI≥28kg/m2 Pregnant or lactating women neuromuscular disorders, hepatic dysfunction, cardiac disease, a history of malignant hyperthermia, or allergic history during general anesthesia patients receiving aminoglycoside antibiotics, anticonvulsants, magnesium,fusidic acid,toremifene and/or flucloxacillin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal transplantation(S group)<br>n=17,CLCR≤30ml/min | Drug: Sugammadex<br>* Each patient received a single dose administration of sugammadex 2mg/kg at reappearance of the second twitch of the train-of-four (TOF).<br>* Other names: Bridion;|
| Experimental: the control group<br>n=17, CLCR≥80ml/min | Drug: Sugammadex<br>* Each patient received a single dose administration of sugammadex 2mg/kg at reappearance of the second twitch of the train-of-four (TOF).<br>* Other names: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Sugammadex | venous blood samples were obtained | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Time and TOF ratio | Time from start of administration of sugammadex to recovery of the T4/T1 Ratio to 0.7 、0.8、0.9 | up to 10 minutes from start of sugammadex | 
| Adverse Event | Percentage of Participants With ≥1 Adverse Event | Up to 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex, renal transplantation