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Sugammadex as Rescue Therapy - Trial NCT05661409

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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NCT05661409
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05661409
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Sugammadex as Rescue Therapy
The Use of Sugammadex as Rescue Therapy Following Inadequate Reversal With Neostigmine

Study Focus

Neuromuscular Blockade

Sugammadex

Interventional

drug

Sponsor & Location

Emory University

Atlanta, United States of America

Timeline & Enrollment

Phase 4

Feb 28, 2023

Jul 01, 2024

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 ฮณ-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 โ‰ฅ 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 bladder
Neuromuscular dysfunction of bladder, unspecified
Neuromuscular scoliosis

Data Source

ClinicalTrials.gov

NCT05661409

Non-Device Trial