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Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries (Sugammadex)

Primary Purpose

Ambulatory Difficulty

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ambulatory Difficulty focused on measuring high risk, chronic health condition, laparoscopic surgery

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    neostigmine

    sugammadex

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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)."

    Secondary Outcome Measures

    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)
    use of additional medications in PACU
    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
    One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.
    patient satisfaction
    At the time of discharge from PACU when patients are fully recovered and conscious, a validated satisfaction survey will be administered.

    Full Information

    First Posted
    April 30, 2019
    Last Updated
    November 14, 2019
    Sponsor
    Montefiore Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03944473
    Brief Title
    Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
    Acronym
    Sugammadex
    Official Title
    Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Stopped before IRB approval
    Study Start Date
    June 20, 2019 (Anticipated)
    Primary Completion Date
    July 20, 2020 (Anticipated)
    Study Completion Date
    July 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Montefiore Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ambulatory Difficulty
    Keywords
    high risk, chronic health condition, laparoscopic surgery

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    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
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    neostigmine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    sugammadex
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Sugammadex
    Intervention Description
    Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent
    Intervention Type
    Drug
    Intervention Name(s)
    Neostigmine
    Intervention Description
    Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent
    Primary Outcome Measure Information:
    Title
    Aldrete Score
    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
    Time Frame
    Up to 5 hours
    Title
    Post Anesthetic Discharge Scoring System
    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
    Time Frame
    Up to 5 hours
    Title
    Fit To PACU Discharge
    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)."
    Time Frame
    Up to 5 hours
    Secondary Outcome Measure Information:
    Title
    Rate of adverse events in PACU
    Description
    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
    Title
    use of additional medications in PACU
    Description
    The research associate will record any medications used in the Post Anesthesia Care Unity (PACU).
    Time Frame
    Up to 5 hours
    Title
    Emergency Department or inpatient admissions within 30 days after discharge
    Description
    One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.
    Time Frame
    30 days after discharge
    Title
    patient satisfaction
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Curtis Choice, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17093366
    Citation
    Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.
    Results Reference
    background
    PubMed Identifier
    28256998
    Citation
    Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.
    Results Reference
    background
    PubMed Identifier
    11740779
    Citation
    Watkins AC, White PF. Fast-tracking after ambulatory surgery. J Perianesth Nurs. 2001 Dec;16(6):379-87. doi: 10.1053/jpan.2001.28887.
    Results Reference
    background
    PubMed Identifier
    11149431
    Citation
    King M, Sujirattanawimol N, Danielson DR, Hall BA, Schroeder DR, Warner DO. Requirements for muscle relaxants during radical retropubic prostatectomy. Anesthesiology. 2000 Dec;93(6):1392-7. doi: 10.1097/00000542-200012000-00008.
    Results Reference
    background
    PubMed Identifier
    18635478
    Citation
    Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
    Results Reference
    background
    PubMed Identifier
    26472231
    Citation
    Martinez-Ubieto J, Ortega-Lucea S, Pascual-Bellosta A, Arazo-Iglesias I, Gil-Bona J, Jimenez-Bernardo T, Munoz-Rodriguez L. Prospective study of residual neuromuscular block and postoperative respiratory complications in patients reversed with neostigmine versus sugammadex. Minerva Anestesiol. 2016 Jul;82(7):735-42. Epub 2015 Oct 16.
    Results Reference
    background
    PubMed Identifier
    25902322
    Citation
    Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
    Results Reference
    background
    PubMed Identifier
    27820709
    Citation
    Brull SJ, Kopman AF. Current Status of Neuromuscular Reversal and Monitoring: Challenges and Opportunities. Anesthesiology. 2017 Jan;126(1):173-190. doi: 10.1097/ALN.0000000000001409.
    Results Reference
    background
    PubMed Identifier
    28926458
    Citation
    Hyman EC, Brull SJ. Clarification: Current Status of Neuromuscular Reversal and Monitoring, Challenges and Opportunities. Anesthesiology. 2017 Oct;127(4):730. doi: 10.1097/ALN.0000000000001795. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26016169
    Citation
    Welliver M, Cheek D, Osterbrink J, McDonough J. Worldwide experience with sugammadex sodium: implications for the United States. AANA J. 2015 Apr;83(2):107-15.
    Results Reference
    background
    PubMed Identifier
    25768376
    Citation
    Soto R, Jahr JS, Pavlin J, Sabo D, Philip BK, Egan TD, Rowe E, de Bie J, Woo T. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial. Am J Ther. 2016 Nov/Dec;23(6):e1654-e1662. doi: 10.1097/MJT.0000000000000206.
    Results Reference
    background
    PubMed Identifier
    28794837
    Citation
    Cho HC, Lee JH, Lee SC, Park SY, Rim JC, Choi SR. Use of sugammadex in lung cancer patients undergoing video-assisted thoracoscopic lobectomy. Korean J Anesthesiol. 2017 Aug;70(4):420-425. doi: 10.4097/kjae.2017.70.4.420. Epub 2017 Apr 21.
    Results Reference
    background
    PubMed Identifier
    24710957
    Citation
    Sabo D, Jahr J, Pavlin J, Philip B, Shimode N, Rowe E, Woo T, Soto R. The increases in potassium concentrations are greater with succinylcholine than with rocuronium-sugammadex in outpatient surgery: a randomized, multicentre trial. Can J Anaesth. 2014 May;61(5):423-32. doi: 10.1007/s12630-014-0128-7. Epub 2014 Apr 8.
    Results Reference
    background
    PubMed Identifier
    27703621
    Citation
    Kim YH. Sugammadex: watch out for new side effects. Korean J Anesthesiol. 2016 Oct;69(5):427-428. doi: 10.4097/kjae.2016.69.5.427. Epub 2016 Sep 8. No abstract available.
    Results Reference
    background

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    Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

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