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

Phase 4

• Conditions: Pharmacodynamics; Pharmacokinetics
• Interventions: Drug: Sugammadex

• Registration Number: NCT04131218
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

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.

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-29
• Last Update Posted: 2020-03-31
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ASA: Ⅰ~Ⅲ
• BMI≥25kg/m²
• Patients receiving bariatric surgery.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese group	Sugammadex	n=8, 25≤BMI≤39.9kg/m²
Morbidly obese group	Sugammadex	n=8, BMI≥40kg/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
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

Trial Locations

Locations (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology; 🇨🇳 Guangzhou, Guangdong, China