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Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine (P-PERSON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02825576
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : August 28, 2020
Merck Sharp & Dohme Corp.
Northern Sydney and Central Coast Area Health Service
Information provided by (Responsible Party):
Northern Sydney Anaesthesia Research Institute

Brief Summary:
The purpose of this study is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).

Condition or disease Intervention/treatment Phase
Pulmonary Complications Drug: Sugammadex Drug: Neostigmine/Glycopyrrolate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Sugammadex group
Sugammadex 2mg/kg intravenously at completion of surgery.
Drug: Sugammadex
Sugammadex 2mg/kg given for reversal agent
Other Name: Bridion

Active Comparator: Neostigmine/Glycopyrrolate group
Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery.
Drug: Neostigmine/Glycopyrrolate
Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent

Primary Outcome Measures :
  1. Incidence of post operative pulmonary complications. [ Time Frame: Up to day 2 post operatively. ]
    Incidence of Postoperative pulmonary complications as defined by The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) group.

Secondary Outcome Measures :
  1. Quality of Recovery Score (QoR-15) [ Time Frame: Day 1 and Day 30 post operatively ]
    A 15- item patient-rated post operative questionnaire designed to assess the early postoperative health status of patients after anesthesia and surgery.

  2. Incidence of post operative nausea and vomiting. [ Time Frame: Day of surgery. ]

    Post Operative Nausea and Vomiting (PONV) Score:

    1. - no PONV
    2. - PONV responsive to antiemetics
    3. - PONV unresponsive to antiemetics

  3. Incidence of airway events in the Post Anaesthesia Care Unit (PACU). [ Time Frame: Day of surgery. ]

    Proportion of patient that exhibit one or more of the following PACU Events (recorded by recovery room nursing staff);

    1. Any desaturation to oxygen saturation by pulse oximetry (SpO2) <90%
    2. Need for manual airway support
    3. Need for oropharyngeal or nasopharyngeal airway
    4. Need for reintubation in PACU
    5. Need for anaesthetist to review the patient
    6. Unplanned Intensive Care Unit (ICU) admission

  4. Mortality [ Time Frame: 30 day ]
    Death of patient within time frame.

  5. Hospital stay [ Time Frame: 30 days ]
    Duration of hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age >18
  • patients presenting for non-cardiac surgery
  • planned operative time of over 1 hour
  • plan to be intubated and to receive muscle relaxants for their surgery
  • plan to stay at least one night in hospital

Exclusion Criteria:

  • Previous recruitment to the trial
  • Hypersensitivity to any of the study drugs
  • Patient refusal
  • Cognitive Impairment, or language proficiency leading to inability to complete QoR-15 questionnaire
  • Body Mass Index (BMI) >40
  • Planned postoperative intubation and ventilation
  • Liver failure with Child-Pugh class B/C
  • Renal failure with either regular peritoneal or haemodialysis or serum creatinine >140mcgmol/L
  • Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02825576

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Contact: Ben L Olesnicky, BMBS Bsc +61 2 9463 2488

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Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Dr Olesnicky         
Sponsors and Collaborators
Northern Sydney Anaesthesia Research Institute
Merck Sharp & Dohme Corp.
Northern Sydney and Central Coast Area Health Service
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Principal Investigator: Ben L Olesnicky, BMBS BSc Northern Sydney Anaesthesia Research Institute
Publications of Results:
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Responsible Party: Northern Sydney Anaesthesia Research Institute Identifier: NCT02825576    
Other Study ID Numbers: MSD-IIS-54809
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists