Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery
- Registration Number
- NCT05328778
- Lead Sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- ASA: Ⅰ~Ⅲ
- BMI≥25kg/m²
- Patients receiving bariatric surgery.
- Pregnant or lactating women
- Neuromuscular diseases
- Malignant hyperthermia or allergic history during general anesthesia
- Drugs that react with rocuronium and vecuronium were taken
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Weight group Sugammadex n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m² Morbidly Obese group Sugammadex n=16, BMI≥40kg/m² Obese group Sugammadex n=16, 25≤BMI≤39.9kg/m²
- Primary Outcome Measures
Name Time Method Plasma Concentration of Sugammadex 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours venous blood samples were obtained
TOF ratio of Recovery Time TOF ratio at 30, 60, 90, 120, 150 seconds after administration time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guangzhou Military Region General Hospital, Department of Anesthesiology
🇨🇳Guangzhou, Guangdong, China