Ambulatory Difficulty
Conditions
Keywords
high risk, chronic health condition, laparoscopic surgery
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.
Interventions
DRUGSugammadex
Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent
DRUGNeostigmine
Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
On the day of surgery, an envelope containing the randomization code will be given to an anesthesiology physician or nurse anesthetist responsible for the clinical care of the study patient. Patients will be randomly allocated to receive neostigmine or sugammadex using a 1:1 allocation ratio. Patients will be stratified based on their ASA physical score. A research associate who is not directly involved with the study procedures will maintain the randomization codes. All others will be blinded
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
Outcome results
None listed