Comparison of Sugammadex and Neostigmine During PACU Stay

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT04096144
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Neuromuscular Blockade

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Neuromuscular Blocking Agents — DRUG
    Neuromuscular agents will be used to block muscle function for the safety and efficiency of the procedure. At the procedure's conclusion, neuromusclar agents such as Neostigmine or Sugammadex will be used to reverse the neuromuscular reversal.

Study Details

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.

Key Dates

Start date
Oct 15, 2019
Status verified
Sep 2019
Primary completion
Mar 1, 2020
Completion
Jun 15, 2020

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Neostigmine
    This is the standard Neuromuscular reversal drug that has been in standard care for the past thirty years. Dose: -Neostigmine: 0.03-0.07 mg/kg by intravenous route.
  • Experimental: Sugammadex
    Used for Neuromuscular reversal; Sugammadex is devoid of the parasympathetic effects caused by Neostigmine. Dose: -Sugammadex: 2-4 mg/kg (4 mg/kg if no twitch responses after initial stimulation), intravenous route.

Primary Outcome Measure

Length of Post Anesthesia Care Unit (PACU) stay [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Enrico M Camporesi, MD
[email protected]
813-600-9094

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By research site
Tampa General Hospital· Tampa, FL

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