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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent
Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent
Aldrete Score
The Aldrete Score will determine transfer from phase 1 to phase 2 recovery. The following criterias will be scored from 0 to 2- activity level, respiration, blood pressure, consciousness, oxygen saturation. Patients who get a total score of 9 or more are considered ready for discharge from Post Anesthesia Care Unit
Time frame: Up to 5 hours
Post Anesthetic Discharge Scoring System
The Post Anesthetic Discharge Scoring System (PADSS) will be used to determine discharge to home readiness. Six criterias to score- vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each one is given a score from 0 to 2. Patients who get a total score of 9 or more are considered ready for discharge from Post Anesthesia Care Unit
Time frame: Up to 5 hours
Fit To PACU Discharge
Based on Post Anesthetic Discharge Scoring System (PADSS), the primary outcome measure will be calculated as the time from study medication administration to the time of "fit to discharge from Post Anesthesia Care Unit (PACU)."
Time frame: Up to 5 hours
Rate of adverse events in PACU
The research associate will record the adverse events related to delay in discharge during stay in Post Anesthesia Care Unit (PACU)
Time frame: Up to 5 hours
use of additional medications in PACU
The research associate will record any medications used in the Post Anesthesia Care Unity (PACU).
Time frame: Up to 5 hours
Emergency Department or inpatient admissions within 30 days after discharge
One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 30 days after discharge
patient satisfaction
At the time of discharge from PACU when patients are fully recovered and conscious, a validated satisfaction survey will be administered.
Time frame: Up to 5 hours