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.
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.
Brief Title
Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Ambulatory Difficulty
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)
* 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)
Inclusion 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
* ASA physical score II and III
* Scheduled for a laparoscopic ambulatory surgery
* 21-60 years of age
* Able to understand and sign informed consent
Gender
All
Gender Based
false
Keywords
high risk
chronic health condition
laparoscopic surgery
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
60 Years
Minimum Age
21 Years
NCT Id
NCT03944473
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10223
Overall Status
Withdrawn
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Primary Outcomes
Outcome Description
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
Outcome Measure
Aldrete Score
Outcome Time Frame
Up to 5 hours
Outcome Description
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
Outcome Measure
Post Anesthetic Discharge Scoring System
Outcome Time Frame
Up to 5 hours
Outcome Description
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)."
Outcome Measure
Fit To PACU Discharge
Outcome Time Frame
Up to 5 hours
Secondary Outcomes
Outcome Description
The research associate will record the adverse events related to delay in discharge during stay in Post Anesthesia Care Unit (PACU)
Outcome Time Frame
Up to 5 hours
Outcome Measure
Rate of adverse events in PACU
Outcome Description
The research associate will record any medications used in the Post Anesthesia Care Unity (PACU).
Outcome Time Frame
Up to 5 hours
Outcome Measure
use of additional medications in PACU
Outcome Description
One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.
Outcome Time Frame
30 days after discharge
Outcome Measure
Emergency Department or inpatient admissions within 30 days after discharge
Outcome Description
At the time of discharge from PACU when patients are fully recovered and conscious, a validated satisfaction survey will be administered.
Outcome Time Frame
Up to 5 hours
Outcome Measure
patient satisfaction
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
60
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Curtis Choice
Investigator Email
cchoice@montefiore.org
Investigator Phone