Clinical trial NCT03944473: Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Official title: Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ambulatory Difficulty
Keywords: high risk
chronic health condition
laparoscopic surgery
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical score II and III
* Scheduled for a laparoscopic ambulatory surgery
* 21-60 years of age
* Able to understand and sign informed consent

Exclusion Criteria:

* Known allergy to neostigmine or sugammadex
* Active pulmonary diagnosis
* American Society of Anesthesia physical score 4 and above
* Known or suspected neuromuscular disease
* Documented renal or liver insufficiency (2 fold increase in the labs)
* Body Mass Index \>40
* Any surgical case brought into the operating room after 4 PM (to avoid any provider bias related to discharging patients before closure of the ambulatory surgery center for the day)

Primary outcomes:
measure: Aldrete Score
timeFrame: Up to 5 hours
measure: Post Anesthetic Discharge Scoring System
timeFrame: Up to 5 hours
measure: Fit To PACU Discharge
timeFrame: Up to 5 hours
Secondary outcomes:
measure: Rate of adverse events in PACU
timeFrame: Up to 5 hours
measure: use of additional medications in PACU
timeFrame: Up to 5 hours
measure: Emergency Department or inpatient admissions within 30 days after discharge
timeFrame: 30 days after discharge
measure: patient satisfaction
timeFrame: Up to 5 hours
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Curtis Choice, MD
role: PRINCIPAL_INVESTIGATOR
References:
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