Pulmonary ComplicationsPhase 4P-PERSONNCT02825576
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
A Phase 4 study testing Sugammadex and Neostigmine/Glycopyrrolate in people with Pulmonary Complications, run by Northern Sydney Anaesthesia Research Institute at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Complications
- What is being tested?
- Sugammadex and Neostigmine/Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Dec 2018to 1 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
The purpose of this study is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).
Read the detailed description
This is a local, multi-centre, prospective, randomised, double blinded trial of 976 patients.
Objectives:
The primary objective is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs). Secondary objectives are to determine if the use of sugammadex compared with traditional reversal agents improves patient quality of recovery, reduces the rate of postoperative nausea and vomiting and reduces the rate of airway complications in the Post Anaesthesia Care Unit (PACU).
Study procedures:
Following informed consent prior to surgery, patients will be randomised to two groups allocating drugs used for reversal of muscle relaxation;
- 2mg/kg sugammadex
- 50mcg/kg neostigmine with 10mcg/kg glycopyrrolate
Randomisation will be via computer generated numbers, which will be sealed in opaque, sequentially numbered envelopes.
Treating anaesthetist and staff assessing outcomes will be blinded to treatment.
Patients will have neuromuscular transmission (NMT) monitoring intraoperatively to ensure return of train-of-four count (TOFC) >2 prior to reversal. Muscle relaxant will be limited to rocuronium or vecuronium, at the choice of the individual anaesthetist. As this study is planned to be a 'real world' trial, mode of anaesthesia, analgesia, postoperative nausea and vomiting (PONV) prophylaxis and time of reversal will be determined by the individual treating anaesthetist.
Postoperative outcome data will be collected in the recovery unit, on postoperative day 1 and 2 (if still an inpatient), at hospital discharge and via a 30 day post-operative phone call.
Statistical Analysis:
Conservatively estimating the baseline incidence of PPC at 7% baseline incidence and an equally conservative estimate that sugammadex can reduce this to 3% would produce a clinically relevant number needed to treat (NNT) of 29. Accepting an alpha error of 0.05 and beta error of 0.2 would require 930 patients. Allowing for 5% incomplete data and loss to follow up requires 976 patients.
Groups will be analysed on an intention-to-treat basis
- PPC rate, QoR-15 score and hospital stay will be assessed as continuous variables
- Post operative Nausea and Vomiting (PONV) score will be assessed as an ordinal variable
- Mortality and the presence of respiratory and PACU events will be assessed as categorical variables.
The effect of sugammadex on continuous variables will be analysed by 2-tailed Student T-test. The effect of sugammadex on ordinal and categorical variables will be analysed by Chi-squared tests. Binomial regression analysis will be performed on the categorical outcomes for the subgroup analyses. Logistic regression will be performed to analyse the effect of PONV risk on PONV scores.
Appropriate statistical tests to confirm test assumptions are met will be performed. In the case of non-parametric data, the appropriate test will be performed. Interim analysis is planned after 50% data completion.
- Conditions
- Pulmonary Complications
- Being tested
- Sugammadex, Neostigmine/Glycopyrrolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Sugammadex 2mg/kg given for reversal agent
Neostigmine/GlycopyrrolateDrug
Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex group | Active comparator | Sugammadex 2mg/kg intravenously at completion of surgery. Receives: Drug: Sugammadex |
| Neostigmine/Glycopyrrolate group | Active comparator | Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery. Receives: Drug: Neostigmine/Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 2 post operatively.
Secondary outcomes (5)
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.
Measured: Day 1 and Day 30 post operatively
Incidence of post operative nausea and vomiting.
Post Operative Nausea and Vomiting (PONV) Score:
- - no PONV
- - PONV responsive to antiemetics
- - PONV unresponsive to antiemetics
Measured: Day of surgery.
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
Measured: Day of surgery.
Mortality
Death of patient within time frame.
Measured: 30 day
Hospital stay
Duration of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start3 Dec 2018
- Primary completion1 Apr 2020
- Study completion1 Jan 2021
Why it stopped: Lack of Study Personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Sydney Anaesthesia Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Northern Sydney and Central Coast Area Health Service
- Responsible party
- Sponsor
- Investigators
- Ben L Olesnicky, BMBS BSc, Principal investigator, Northern Sydney Anaesthesia Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825576
- Sponsor's protocol ID
- MSD-IIS-54809
- Acronym
- P-PERSON
- Status last verified
- Mar 2023
- First submitted
- 21 Jun 2016
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Olesnicky B, Doane M, Farrell C, Knoblanche G, Delaney A. Prevention of Postoperative Events following Reversal with Sugammadex or Neostigmine (the P-PERSoN Trial): Pilot Data Following Early Termination of a Prospective, Blinded, Randomised Trial. Anesthesiol Res Pract. 2022 Jul 8;2022:4659795. doi: 10.1155/2022/4659795. eCollection 2022.
PubMed 35844810
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
- ClinicalTrials.gov ID
- NCT02825576
- Acronym / sponsor ID
- P-PERSON / MSD-IIS-54809
- Conditions
- Pulmonary Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Study Personnel
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northern Sydney Anaesthesia Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Northern Sydney and Central Coast Area Health Service
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).
Detailed description
This is a local, multi-centre, prospective, randomised, double blinded trial of 976 patients.
Objectives:
The primary objective is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs). Secondary objectives are to determine if the use of sugammadex compared with traditional reversal agents improves patient quality of recovery, reduces the rate of postoperative nausea and vomiting and reduces the rate of airway complications in the Post Anaesthesia Care Unit (PACU).
Study procedures:
Following informed consent prior to surgery, patients will be randomised to two groups allocating drugs used for reversal of muscle relaxation;
- 2mg/kg sugammadex
- 50mcg/kg neostigmine with 10mcg/kg glycopyrrolate
Randomisation will be via computer generated numbers, which will be sealed in opaque, sequentially numbered envelopes.
Treating anaesthetist and staff assessing outcomes will be blinded to treatment.
Patients will have neuromuscular transmission (NMT) monitoring intraoperatively to ensure return of train-of-four count (TOFC) >2 prior to reversal. Muscle relaxant will be limited to rocuronium or vecuronium, at the choice of the individual anaesthetist. As this study is planned to be a 'real world' trial, mode of anaesthesia, analgesia, postoperative nausea and vomiting (PONV) prophylaxis and time of reversal will be determined by the individual treating anaesthetist.
Postoperative outcome data will be collected in the recovery unit, on postoperative day 1 and 2 (if still an inpatient), at hospital discharge and via a 30 day post-operative phone call.
Statistical Analysis:
Conservatively estimating the baseline incidence of PPC at 7% baseline incidence and an equally conservative estimate that sugammadex can reduce this to 3% would produce a clinically relevant number needed to treat (NNT) of 29. Accepting an alpha error of 0.05 and beta error of 0.2 would require 930 patients. Allowing for 5% incomplete data and loss to follow up requires 976 patients.
Groups will be analysed on an intention-to-treat basis
- PPC rate, QoR-15 score and hospital stay will be assessed as continuous variables
- Post operative Nausea and Vomiting (PONV) score will be assessed as an ordinal variable
- Mortality and the presence of respiratory and PACU events will be assessed as categorical variables.
The effect of sugammadex on continuous variables will be analysed by 2-tailed Student T-test. The effect of sugammadex on ordinal and categorical variables will be analysed by Chi-squared tests. Binomial regression analysis will be performed on the categorical outcomes for the subgroup analyses. Logistic regression will be performed to analyse the effect of PONV risk on PONV scores.
Appropriate statistical tests to confirm test assumptions are met will be performed. In the case of non-parametric data, the appropriate test will be performed. Interim analysis is planned after 50% data completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex group | Active comparator | Drug: SugammadexSugammadex 2mg/kg intravenously at completion of surgery. |
| Neostigmine/Glycopyrrolate group | Active comparator | Drug: Neostigmine/GlycopyrrolateNeostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: BridionSugammadex 2mg/kg given for reversal agent | Drug | Sugammadex group |
| Neostigmine/GlycopyrrolateNeostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent | Drug | Neostigmine/Glycopyrrolate group |
Primary outcome
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.
5 secondary outcomes
Quality of Recovery Score (QoR-15)
Time frame: Day 1 and Day 30 post operatively
Incidence of post operative nausea and vomiting.
Time frame: Day of surgery.
Incidence of airway events in the Post Anaesthesia Care Unit (PACU).
Time frame: Day of surgery.
Mortality
Time frame: 30 day
Hospital stay
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Lack of Study Personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Results publication: PubMed 35844810Olesnicky B, Doane M, Farrell C, Knoblanche G, Delaney A. Prevention of Postoperative Events following Reversal with Sugammadex or Neostigmine (the P-PERSoN Trial): Pilot Data Following Early Termination of a Prospective, Blinded, Randomised Trial. Anesthesiol Res Pract. 2022 Jul 8;2022:4659795. doi: 10.1155/2022/4659795. eCollection 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben L Olesnicky, BMBS BSc principal investigator
Northern Sydney Anaesthesia Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex and Neostigmine/Glycopyrrolate in people with Pulmonary Complications, run by Northern Sydney Anaesthesia Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Study Personnel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post operative pulmonary complications. (time frame: Up to day 2 post operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.