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

G

Guangzhou General Hospital of Guangzhou Military Command

Status and phase

Enrolling
Phase 4

Conditions

Pharmacokinetics

Treatments

Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT05328778
Laparoscopic Surgery

Details and patient eligibility

About

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

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 3 patient groups

Normal Weight group
Experimental group
Description:
n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²
Treatment:
Drug: Sugammadex
Obese group
Experimental group
Description:
n=16, 25≤BMI≤39.9kg/m²
Treatment:
Drug: Sugammadex
Morbidly Obese group
Experimental group
Description:
n=16, BMI≥40kg/m²
Treatment:
Drug: Sugammadex

Trial contacts and locations

1

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Central trial contact

Bo Xu

Data sourced from clinicaltrials.gov

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