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NCT04096144
Comparison of Sugammadex and Neostigmine During PACU Stay
Phase 3 trial testing Neuromuscular Blocking Agents in Neuromuscular Blockade in 50 participants. Not yet recruiting.
1 March 2020
Quick facts
| Lead sponsor | University of South Florida |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 15 October 2019 |
| Primary completion | 1 March 2020 |
| Estimated completion | 15 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Neuromuscular Blocking Agents — full drug profile →
Conditions studied
- Neuromuscular Blockade — all drugs for Neuromuscular Blockade →
Sponsor
University of South Florida
Who can join
Adults 18 to 65, any sex, with Neuromuscular Blockade. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sugammadex was approved for post-operative use in the operating room (OR) and post-anesthesia recovery unit (PACU) of our quaternary facility, Tampa General Hospital. The approval came with administrative limitations: 2mg/kg dose only and for the first year its utilization was limited as replacement for up to half of Neostigmine/Glycopyrrolate use. An MUE evaluation was completed for a retrospective chart review from March 2017 to December 2017 (10 months) to assess all cases in which patients received Sugammadex or Neostigmine. During the year of data collection, we also noted a widespread tendency to reduce the usage of narcotics. A t-test comparison of the length of stay (LOS) in the PACU revealed a highly significant difference between the LOS in PACU for both drugs. On average, patients receiving Sugammadex were discharged from the PACU 43 minutes earlier than patients who received Neostigmine/Glycopyrrolate. The patient mix in both groups was similar, but these data were obtained retrospectively by a pharmacy chart review.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04096144
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04096144 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Florida
- Last refreshed: 19 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04096144.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing