NCT05328778

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

March 4, 2022

Last Update Submit

April 15, 2026

Conditions

Pharmacokinetics

Keywords

SugammadexLaparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Normal Weight group

EXPERIMENTAL

n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²

Drug: Sugammadex

Obese group

EXPERIMENTAL

n=16, 25≤BMI≤39.9kg/m²

Drug: Sugammadex

Morbidly Obese group

EXPERIMENTAL

n=16, BMI≥40kg/m²

Drug: Sugammadex

Interventions

SugammadexDRUG

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).

Also known as: Bridion, Org 25969
Morbidly Obese groupNormal Weight groupObese group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA: Ⅰ\~Ⅲ
  • BMI≥25kg/m²
  • Patients receiving bariatric surgery.

You may not qualify if:

  • Pregnant or lactating women
  • Neuromuscular diseases
  • Malignant hyperthermia or allergic history during general anesthesia
  • Drugs that react with rocuronium and vecuronium were taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 14, 2022

Study Start

April 14, 2022

Primary Completion

January 1, 2025

Study Completion

April 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

CN(1)