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

Guangzhou General Hospital of Guangzhou Military Command

Status and phase: Unknown; Phase 4

Conditions: Pharmacodynamics; Pharmacokinetics

Treatments: Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT04131218

PK and PD of Sug

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Obese group

Experimental group

Description:

n=8, 25≤BMI≤39.9kg/m²

Treatment:

Drug: Sugammadex

Morbidly obese group

Experimental group

Description:

n=8, BMI≥40kg/m²

Treatment:

Drug: Sugammadex