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

Sponsor

Guangzhou General Hospital of Guangzhou Military Command (Other)

Overall Status

Recruiting

CT.gov ID

NCT05328778

Collaborator

(none)

Enrollment

Location

Arms

40.5

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: Sugammadex	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 16, 2019

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal Weight group n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²	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). Other Names: Bridion Org 25969
Experimental: Obese group n=16, 25≤BMI≤39.9kg/m²	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). Other Names: Bridion Org 25969
Experimental: Morbidly Obese group n=16, BMI≥40kg/m²	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). Other Names: Bridion Org 25969

Arm

Intervention/Treatment

Experimental: Normal Weight group

n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²

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).

Other Names:

Bridion

Org 25969

Experimental: Obese group

n=16, 25≤BMI≤39.9kg/m²

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).

Other Names:

Bridion

Org 25969

Experimental: Morbidly Obese group

n=16, BMI≥40kg/m²

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).

Other Names:

Bridion

Org 25969

Outcome Measures

Primary Outcome Measures

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
TOF ratio of Recovery Time [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong	China	510010

Sponsors and Collaborators

Guangzhou General Hospital of Guangzhou Military Command

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

bo xu, Clinical Professor, Guangzhou General Hospital of Guangzhou Military Command

ClinicalTrials.gov Identifier:

NCT05328778

Other Study ID Numbers:

Laparoscopic Surgery

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by bo xu, Clinical Professor, Guangzhou General Hospital of Guangzhou Military Command

Sugammadex

Laparoscopic Surgery

Study Results

No Results Posted as of Apr 14, 2022