NCT05328778

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Guangzhou General Hospital of Guangzhou Military Command · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Sugammadex	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).

Timeline

• Start date: 2019-07-16
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-04-14
• Last updated: 2022-04-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study