Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

Phase 4

Withdrawn

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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
neostigmine	Neostigmine	Neostigmine is the acetylcholinesterase inhibitor most commonly used in pharmacologically reversing the effects of neuromuscular blockers \[8\]. Reversal of NMB is facilitated by increasing acetylcholine levels at nicotinic skeletal muscle-binding sites.
sugammadex	Sugammadex	Sugammadex is a modified gamma-cyclodextrin, the first of a new class of drugs called selective relaxant binding agents, with an unusually high affinity for rocuronium. This medication offers an alternate mechanism of action to antagonize the effects of steroidal neuromuscular blockade agents.

Primary Outcome Measures

Name	Time	Method
Aldrete Score	Up to 5 hours	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
Post Anesthetic Discharge Scoring System	Up to 5 hours	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
Fit To PACU Discharge	Up to 5 hours	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)."

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events in PACU	Up to 5 hours	The research associate will record the adverse events related to delay in discharge during stay in Post Anesthesia Care Unit (PACU)
use of additional medications in PACU	Up to 5 hours	The research associate will record any medications used in the Post Anesthesia Care Unity (PACU).
Emergency Department or inpatient admissions within 30 days after discharge	30 days after discharge	One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.
patient satisfaction	Up to 5 hours	At the time of discharge from PACU when patients are fully recovered and conscious, a validated satisfaction survey will be administered.