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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05328778
Enrollment
48
Registered
2022-04-14
Start date
2022-04-14
Completion date
2026-04-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

Sugammadex, Laparoscopic Surgery

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

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.

Interventions

DRUGSugammadex

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).

Sponsors

Guangzhou General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Concentration of Sugammadex0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hoursvenous blood samples were obtained
TOF ratio of Recovery TimeTOF ratio at 30, 60, 90, 120, 150 seconds after administrationtime from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026