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NCT05661409 · ClinicalTrials.gov registry record · Phase 4
Sugammadex as Rescue Therapy
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT05661409 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 46 participants.
The verdict
NCT05661409, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study 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
Interventions
- DRUG Placebo
- DRUG Sugammadex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2023-07-21 |
| Est. Completion | 2024-08-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05661409
The ClinicalTrials.gov registry entry for NCT05661409 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05661409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05661409 about?
NCT05661409 is a clinical study titled "Sugammadex as Rescue Therapy". 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 ...
What is the current status of trial NCT05661409?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2023-07-21. Estimated completion is 2024-08-02.
What interventions are being tested in trial NCT05661409?
The interventions under investigation include: Placebo (DRUG), Sugammadex (DRUG).
Who is sponsoring clinical trial NCT05661409?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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