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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328778
• Other study ID #: Laparoscopic Surgery
• Status: Recruiting
• Phase: Phase 4
• Start date: July 16, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2022
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Bo Xu
• Phone: 88653387
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. ASA: ?~?

2. BMI=25kg/m²

3. Patients receiving bariatric surgery.

Exclusion Criteria:

1. Pregnant or lactating women

2. Neuromuscular diseases

3. Malignant hyperthermia or allergic history during general anesthesia

4. Drugs that react with rocuronium and vecuronium were taken

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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).

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Sugammadex	venous blood samples were obtained	0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours
Primary	TOF ratio of Recovery Time	time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators	TOF ratio at 30, 60, 90, 120, 150 seconds after administration