Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Plasma Concentration of Sugammadex
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Normal Weight group
n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²
Intervention: Sugammadex (Drug)
Morbidly Obese group
n=16, BMI≥40kg/m²
Intervention: Sugammadex (Drug)
Obese group
n=16, 25≤BMI≤39.9kg/m²
Intervention: Sugammadex (Drug)
Outcomes
Primary Outcomes
Plasma Concentration of Sugammadex
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
bo xu
Clinical Professor
Guangzhou General Hospital of Guangzhou Military Command