Skip to main content
OpenTrials
Completed

NCT Number: NCT05328778

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

The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

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).

Other names: Bridion, Org 25969

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 14, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.