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

NCT ID: NCT05328778

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal Weight group

n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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).

Obese group

n=16, 25≤BMI≤39.9kg/m²

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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).

Morbidly Obese group

n=16, BMI≥40kg/m²

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Bridion Org 25969

Eligibility Criteria

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Inclusion Criteria

1. ASA: Ⅰ\~Ⅲ
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

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bo xu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bo Xu

Role: CONTACT

88653387 ext. 020

Facility Contacts

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Yan Lu

Role: primary

15083521991 ext. 86

Other Identifiers

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Laparoscopic Surgery

Identifier Type: -

Identifier Source: org_study_id

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