Ambulatory Difficulty Clinical Trial
Official title:
Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
In this randomized controlled study, the investigators hypothesize that sugammadex is
superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in
an urban, stand-alone ambulatory surgery center.
The primary objective of this study is to evaluate the "fit to discharge time in the PACU."
The secondary objectives are PACU adverse events, use of additional medications in the PACU,
0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at
discharge.
There is limited published data in the use of sugammadex for high-risk patient populations,
such as those undergoing laparoscopic procedures in standalone outpatient surgery facilities.
About 90% of the ambulatory surgical patient population at this institution is non-caucasian
with the majority of the higher-risk patients having obesity and one or more additional
chronic health conditions. In this randomized controlled study, the investigators hypothesize
that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic
outpatient surgery in an urban, stand-alone ambulatory surgery center.
The primary objective of this study is to evaluate the "fit to discharge time in the PACU."
The secondary objectives are PACU adverse events, use of additional medications in the PACU,
0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at
discharge.
In this double-blinded randomized controlled study, the study team is evaluating the efficacy
and safety of sugammadex in patients undergoing ambulatory surgical procedures. Currently,
both neostigmine and sugammadex are standard of care in this institution. Other than the
emergent need for NMB reversal, practice preference and individual indications dictate the
selection of reversal medication.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05736484 -
Randomized Clinical Trial to Improve Mobility After Hospitalization
|
N/A |