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Comparison of Sugammadex and Neostigmine During PACU Stay

ConditionNeuromuscular Blockade
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of South Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-75 years of age

Patients with surgeries with duration of 90-120 minutes

ASA Patients I-III (Appendix A)

Patients admitted to TGH for abdominal hernia repair, cholecystectomy and/or abdominal surgery as performed by Dr. Albrink

Disqualifiers

<18 years of age

ASA Patients IV and above (Appendix A)

Patients with allergic reactions to Neostigmine+Glycopyrrolate and/or Sugammadex

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: NeostigmineExperimental treatment 1 intervention
Group B: SugammadexExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Length of Post Anesthesia Care Unit (PACU) stay

Time spent in the recovery room (PACU).

Time frame
6 months
2

Pain (Visual Analog Scale) VAS scores

Evaluation of the level of pain

Time frame
6 months
3

Aldrete Score

Evaluation of level of alertness of the patient at the conclusion of PACU stay for discharge.

Time frame
6 months
4

Pulse Oximetry

Finger Saturation

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: