Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

Conditions
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Ambulatory Difficulty

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: neostigmine<br>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. | Drug: Neostigmine<br>* Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent<br>|
| Experimental: sugammadex<br>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. | Drug: Sugammadex<br>* Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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). | Up to 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 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. | 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. | Up to 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk, chronic health condition, laparoscopic surgery