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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02825576
Registration number
NCT02825576
Ethics application status
Date submitted
21/06/2016
Date registered
7/07/2016
Date last updated
29/03/2023
Titles & IDs
Public title
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
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Scientific title
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
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Secondary ID [1]
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MSD-IIS-54809
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Universal Trial Number (UTN)
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Trial acronym
P-PERSON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Complications
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sugammadex
Treatment: Drugs - Neostigmine/Glycopyrrolate
Active Comparator: Sugammadex group - Sugammadex 2mg/kg intravenously at completion of surgery.
Active Comparator: Neostigmine/Glycopyrrolate group - Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery.
Treatment: Drugs: Sugammadex
Sugammadex 2mg/kg given for reversal agent
Treatment: Drugs: Neostigmine/Glycopyrrolate
Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of post operative pulmonary complications.
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Assessment method [1]
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Incidence of Postoperative pulmonary complications as defined by The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) group.
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Timepoint [1]
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Up to day 2 post operatively.
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Secondary outcome [1]
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Quality of Recovery Score (QoR-15)
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Assessment method [1]
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A 15- item patient-rated post operative questionnaire designed to assess the early postoperative health status of patients after anesthesia and surgery.
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Timepoint [1]
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Day 1 and Day 30 post operatively
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Secondary outcome [2]
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Incidence of post operative nausea and vomiting.
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Assessment method [2]
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Post Operative Nausea and Vomiting (PONV) Score:
- no PONV
- PONV responsive to antiemetics
- PONV unresponsive to antiemetics
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Timepoint [2]
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Day of surgery.
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Secondary outcome [3]
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Incidence of airway events in the Post Anaesthesia Care Unit (PACU).
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Assessment method [3]
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Proportion of patient that exhibit one or more of the following PACU Events (recorded by recovery room nursing staff);
Any desaturation to oxygen saturation by pulse oximetry (SpO2) <90%
Need for manual airway support
Need for oropharyngeal or nasopharyngeal airway
Need for reintubation in PACU
Need for anaesthetist to review the patient
Unplanned Intensive Care Unit (ICU) admission
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Timepoint [3]
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Day of surgery.
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Secondary outcome [4]
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Mortality
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Assessment method [4]
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Death of patient within time frame.
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Timepoint [4]
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30 day
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Secondary outcome [5]
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Hospital stay
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Assessment method [5]
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Duration of hospital stay
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Timepoint [5]
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30 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2021
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Northern Sydney Anaesthesia Research Institute
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Northern Sydney and Central Coast Area Health Service
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02825576
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ben L Olesnicky, BMBS BSc
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Address
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Northern Sydney Anaesthesia Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02825576
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