Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery

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 vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery

Detailed Description
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48 patients undergoing laparoscopic surgery were divided into 3 groups according to body mass index (BMI), including normal weight group(A group,n=16,18.5kg/m² ≤ BMI ≤ 24.9kg/m²),obese group (B group, n=16, 25≤BMI≤39.9kg/m²) and morbidly obese group (C group, n=16, BMI≥40kg/m²). Vecuronium was continuous infusing to maintain moderate neuromuscular blockade during the laparoscopic surgery and stopped infusing after the laparoscopic procedure. A single dose administration of sugammadex (Sug) 2.0mg/kg according to ideal body weight (IBW) was given at the reappearance of the second twitch of the train-of-four (TOF) response. On one hand, venous blood samples were obtained before administration of Sug and at 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours after administration of Sug to determine plasma concentration of Sug using HPLC-MS. On the other hand, time from start of administration of Sug to recovery of TOF ratio to 0.9 and other clinical indicators were also recorded.

Official Title
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Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery

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: ASA: Ⅰ Ⅲ BMI≥25kg/m² Patients receiving bariatric surgery. Exclusion Criteria: Pregnant or lactating women Neuromuscular diseases Malignant hyperthermia or allergic history during general anesthesia Drugs that react with rocuronium and vecuronium were taken

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Normal Weight group<br>n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m² | Drug: Sugammadex<br>* Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).<br>* Other names: Org 25969;|
| Experimental: Obese group<br>n=16, 25≤BMI≤39.9kg/m² | Drug: Sugammadex<br>* Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).<br>* Other names: Org 25969;|
| Experimental: Morbidly Obese group<br>n=16, BMI≥40kg/m² | Drug: Sugammadex<br>* Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).<br>* Other names: Org 25969;|

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 | 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours | 
| TOF ratio of Recovery Time | time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators | TOF ratio at 30, 60, 90, 120, 150 seconds after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex, Laparoscopic Surgery