NCT05661409

Sugammadex as Rescue Therapy

The Use of Sugammadex as Rescue Therapy Following Inadequate Reversal With Neostigmine
Emory University·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Neuromuscular Blockade
Drug/Device/Intervention
Sugammadex
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Emory University
Location
Atlanta, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Feb 28, 2023
End date
Jul 01, 2024
Enrollment
36 participants
Primary outcome

The time taken to achieve a TOF ratio of 0.9 after administration sugammadex

Summary

Neuromuscular blocking agents (NMBAs) are commonly used in the practice of anesthesiology for
 skeletal muscle relaxation to facilitate tracheal intubation, mechanical ventilation, and to
 provide optimal surgical conditions. In order to prevent residual NMB, it is vital to
 adequately reverse any use of a non-depolarizing NMBA. This was historically done using an
 anticholinesterase such as neostigmine, which would increase the concentration of
 acetylcholine at the neuromuscular junction leading to the return of neuromuscular
 transmission. Unfortunately, there are disadvantages to the use of an anticholinesterase. It
 was in this context that sugammadex was found to be a valuable addition to the
 anesthesiologist's armamentarium. It is a modified γ-cyclodextrin that encapsulates the
 aminosteroid NMBAs rocuronium and vecuronium.
 
 This project is a double-blind randomized placebo-controlled dose-response trial that aims to
 determine the time taken to achieve adequate reversal comparing five doses of sugammadex as
 rescue therapy following inadequate reversal with neostigmine. The study team will recruit
 patients aged 18 years and above from the main operating room and outpatient surgery center
 at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who
 has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3
 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given. Those with a
 TOF count 3 twitches will drop out of the study as there are already specified doses of
 sugammadex for that level of NMB

ICD-10 classifications
Skeletal muscle relaxants [neuromuscular blocking agents]Poisoning: Skeletal muscle relaxants [neuromuscular blocking agents]Other neuromuscular dysfunction of bladderNeuromuscular dysfunction of bladder, unspecifiedNeuromuscular scoliosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05661409
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05661409 through Pure Global AI's free database. This Phase 4 trial is sponsored by Emory University and is currently Not yet recruiting. The study focuses on Neuromuscular Blockade. Target enrollment is 36 participants.

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