Pharmacokinetics and Pharmacodynamics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade

Pharmacokinetics and Pharmacodynamics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Anesthesia Obese Patients Undergoing Bariatric Surgery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04131218

Enrollment

Registered

2019-10-18

Start date

2019-07-16

Completion date

2020-07-31

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacodynamics, Pharmacokinetics

Keywords

Sugammadex, Obese

Brief summary

The purpose of this study is to illustrate pharmacokinetics and pharmacodynamics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in anesthesia obese patients undergoing bariatric surgery.

Detailed description

16 obese patients undergoing bariatric surgery were divided into 2 groups according to body mass index (BMI), including obese group (O group, n=8, 25≤BMI≤39.9kg/m²) and morbidly obese group (M group, n=8, 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.

Interventions

DRUGSugammadex

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).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
Recovery Time and TOF ratio	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026