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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02825576




Registration number
NCT02825576
Ethics application status
Date submitted
21/06/2016
Date registered
7/07/2016
Date last updated
28/08/2020

Titles & IDs
Public title
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Scientific title
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Secondary ID [1] 0 0
MSD-IIS-54809
Universal Trial Number (UTN)
Trial acronym
P-PERSON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Complications 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of post operative pulmonary complications. - Incidence of Postoperative pulmonary complications as defined by The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) group.
Timepoint [1] 0 0
Up to day 2 post operatively.
Secondary outcome [1] 0 0
Quality of Recovery Score (QoR-15) - A 15- item patient-rated post operative questionnaire designed to assess the early postoperative health status of patients after anesthesia and surgery.
Timepoint [1] 0 0
Day 1 and Day 30 post operatively
Secondary outcome [2] 0 0
Incidence of post operative nausea and vomiting. - Post Operative Nausea and Vomiting (PONV) Score:
- no PONV
- PONV responsive to antiemetics
- PONV unresponsive to antiemetics
Timepoint [2] 0 0
Day of surgery.
Secondary outcome [3] 0 0
Incidence of airway events in the Post Anaesthesia Care Unit (PACU). - 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
Timepoint [3] 0 0
Day of surgery.
Secondary outcome [4] 0 0
Mortality - Death of patient within time frame.
Timepoint [4] 0 0
30 day
Secondary outcome [5] 0 0
Hospital stay - Duration of hospital stay
Timepoint [5] 0 0
30 days

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Northern Sydney Anaesthesia Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Sydney and Central Coast Area Health Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT02825576
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben L Olesnicky, BMBS BSc
Address 0 0
Northern Sydney Anaesthesia Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ben L Olesnicky, BMBS Bsc
Address 0 0
Country 0 0
Phone 0 0
+61 2 9463 2488
Fax 0 0
Email 0 0
bolesnicky@hotmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02825576