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Diaphragm Ultrasound to Evaluate the Antagonistic Effect of Sugammadex

NCT05028088 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2021-09-05

No results posted yet for this study

Summary

The use of muscle relaxants is an indispensable in the general anesthesia but is prone to accidents, which are often related to residual muscle relaxant. Therefore, how to timely and effectively eliminate the residual effect of muscle relaxants after surgery has become an urgent clinical problem. Rocuronium is a non-depolarizing muscle relaxant that is primarily metabolized by the liver. Patients with liver dysfunction can affect the metabolic process of rocuronium, thereby delaying the recovery of muscle relaxation. Sugammadex (SUG) is a novel specific antagonist of aminosteroid muscle relaxants, which can effectively antagonize muscle relaxants at different depths. However, whether liver dysfunction affects the antagonistic effect of SUG against rocuronium has not been reported yet. Therefore, the investigators hypothesize that with the increase of patients' liver Child-Pugh grade, the recovery time of rocuronium antagonized by the same dose of SUG after surgery will be prolonged, and the incidence of muscle relaxation residual will be increased in the short term.

Conditions

  • Diaphragm Ultrasonography
  • Liver Dysfunction
  • Sugammadex
  • Rocuronium

Interventions

DRUG

sugammadex

This study is a prospective, double-blind, low-intervention, non-randomized controlled clinical trial involving 99 patients with American Society of Anesthesiologists Ⅰ-Ⅲ, body mass index 18.5-24.9 kg/m2, who will undergo laparoscopic radical resection of liver cancer under general anesthesia in the Wuhan Union Hospital. Ultrasonography will be applied to monitor the change rate of diaphragm thickness at different time after extubation to evaluate the recovery rate of muscle relaxant, which indirectly reflects the dose-effect relationship of SUG antagonizing against rocuronium in patients with different liver Child-Pugh grades preoperatively.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Yun Lin, MD, PhD. · Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05028088 on ClinicalTrials.gov