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Comparison of Sugammadex and Neostigmine During PACU Stay

NCT04096144 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Neuromuscular Blockade

Interventions

DRUG

Neuromuscular Blocking Agents

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.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Enrico M Camporesi, MD · TEAMHealth Anesthesia/Tampa General Hospital

  • Maha Balouch, MA · TEAMHealth Anesthesia/Tampa General Hospital

  • Michael Albrink, MD · Tampa General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2020-03-01
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096144 on ClinicalTrials.gov