ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616000063415

Ethics application status

Approved

Date submitted

19/01/2016

Date registered

21/01/2016

Date last updated

4/11/2022

Date data sharing statement initially provided

3/12/2018

Date results provided

4/11/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of sugammadex on respiratory complications and patient satisfaction following surgery

Scientific title

Does the use of sugammadex for reversal of paralysis reduce postperative pulmonary events when compared with neostigmine following general anaesthesia

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1177-4335

Trial acronym

P-PERSoN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory Complications of Surgery

Patient Quality of Recovery

Recovery Room Complications Post Surgery

Postoperative Nausea and Vomiting

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

2mg/kg intravenous sugammadex at completion of surgery

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

0.5mg/kg neostigmine and 0.01mg/kg glycopyrullate at completion of surgery.

Control group

Active

Outcomes

Primary outcome [1]

Any of the following postoperative pulmonary complications (as defined by the ARISCAT group) - composite outcome; 1. Respiratory failure – Postoperative Pao2 <60 mmHg on room air, a ratio of Pao2 to inspired oxygen fraction <300, or arterial oxyhemoglobin saturation measured with pulse oximetry <90% and requiring oxygen therapy 2. Suspected pulmonary infection; Treatment with antibiotics for a respiratory infection, plus at least one of the following criteria: New or changed sputum, New or changed lung opacities on a clinically indicated chest radiograph, Temperature >38.3°C, Leukocyte count >12,000/mm 3. Pleural effusion - Chest radiograph demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm (in upright position), evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows 4. Atelectasis - Suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm toward the affected area, and compensatory overinflation in the adjacent nonatelectatic lung 5. Pneumothorax - Air in the pleural space with no vascular bed surrounding the visceral pleura 6. Bronchospasm - Newly detected expiratory wheezing treated with bronchodilators 7. Aspiration pneumonitis - Respiratory failure after the inhalation of regurgitated gastric contents

Timepoint [1]

day 1 and 2 postoperatively and at hospital discharge

Secondary outcome [1]

Quality of Recovery Score (QoR-15)

Timepoint [1]

Day 1 and 30 post operatively

Secondary outcome [2]

Post operative nausea and vomiting score
1 – no PONV
2 – PONV responsive to antiemetics
3 – PONV unresponsive to antiemetics

Timepoint [2]

During Recovery Room Stay

Secondary outcome [3]

Mortality

Timepoint [3]

30-day

Secondary outcome [4]

Patient reported ‘chest infection’ requiring antibiotics since operation or patient reported need for NEW or INCREASED bronchodilator therapy since operation (at follow up phone call).

Timepoint [4]

30 day

Secondary outcome [5]

Proportion of patient that exhibit one or more of the following PACU Events (recorded by recovery room nursing staff);
1. Any desaturation to 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 ICU admission

Timepoint [5]

During Recovery Room Stay

Secondary outcome [6]

Hospital Stay, recorded from medical record.

Timepoint [6]

days (assessed at 30 days from medical record)

Eligibility

Key inclusion criteria

age >18
patients presenting for non-cardiac surgery
planned operative time of over 2 hours
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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previous recruitment to the trial
Patient refusal
Weight>200kg
Planned postoperative intubation and ventilation
Hypersensitivity reactions to any of the study drugs
Mechanical obstruction of the intestinal or urinary tracts
Peritonitis
Liver failure with Child-Pugh class B/C
Renal failure with either regular peritoneal or haemodialysis or serum creatinine >140mcgmol/L

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)

Treating Anaesthetist and staff assessing outcomes blinded to treatment. Randomisation will be via computer generated numbers, which will be sealed in opaque, sequentially numbered envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomisation to group.

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

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The largest prospective study looking at a defined set of postoperative pulmonary complications showed an overall incidence of 7.9%. Based on a conservative estimate of 7% baseline incidence and a conservative estimate that sugamamdex can reduce this to 3% (based on our retrospective study showing an odds reduction of 0.28, which would reduce the incidence to 1.96%) would produce a clinically relevant 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.

Statistical analysis will be performed based on the outcome.
1. PPC rate, QoR-40 score, hospital stay will be assessed as continuous variables
2. PONV score will be assessed as an ordinal variable
3. 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.

Statistical tests appropriate to confirm test assumptions are met will be performed.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Other reasons/comments

Other reasons

COVID stopped recruitment for 18 months

Date of first participant enrolment

Anticipated

1/04/2017

Actual

3/12/2018

Date of last participant enrolment

Anticipated

1/01/2019

Actual

1/01/2019

Date of last data collection

Anticipated

31/01/2019

Actual

31/01/2020

Sample size

Target

976

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

North Shore Private Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - Royal North Shore Hospital

Recruitment postcode(s) [2]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Northern Sydney Anaesthetic Research Institute (NSARI)

Address [1]

c/- Dept of Anaesthesia, Level 4,
Royal North Shore Hospital,
Reserve Rd,
St Leonards, NSW 2065

Country [1]

Australia

Primary sponsor type

Other

Name

Northern Sydney Anaesthetic Research Institute (NSARI)

Address

C/- Dept of Anaesthesia, Level 4
Royal North Shore Hospital,
Reserve Rd,
St Leonards,
2065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee (NSLHD HREC)

Ethics committee address [1]

Level 13 Kolling Building
Royal North Shore Hospital
Reserve Rd
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2016

Approval date [1]

27/01/2017

Ethics approval number [1]

HREC/16/HAWKE/433

Summary

Brief summary

In anaesthesia, traditional agents used for the reversal of paralytic agents are designed around the use of an anticholinesterase inhibitor (commonly neostigmine) to increase motor end plate acetylcholine. This is usually combined with an anti-muscarinic agent (atropine or glycopyrullate) to offset the autonomic effects of excess acetylcholine. Sugammadex is a newer agent that works via encapsulation of aminosteroid neuromuscular blocking agents. Whether or not sugammadex is superior to neostigmine based techniques in terms of prevention of the morbidity associated with residual paralysis have never been shown in a prospective randomised trial. P-PERSoN is a prospective multi-centre, double blinded, randomised controlled trial to compare neostigmine/glycopyrullate and sugammadex reversal. The primary outcome is all in-hospital respiratory events. Secondary outcomes will be, recovery room airway and desaturation events, hospital stay, quality of recovery scores, all-cause 30-day mortality and respiratory morbidity.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Benjamin Olesnicky

Address

c/- Dept of Anaesthesia, Level 4,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9463 2488

Fax

bolesnicky@hotmail.com

Contact person for public queries

Name

Benjamin Olesnicky

Address

c/- Dept of Anaesthesia, Level 4,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9463 2488

Fax

bolesnicky@hotmail.com

Contact person for scientific queries

Name

Benjamin Olesnicky

Address

c/- Dept of Anaesthesia, Level 4,
Royal North Shore Hospital,
Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9463 2488

Fax

bolesnicky@hotmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17537	Clinical study report	Benjamin Olesnicky, Matthew Doane, Clare Farrell, Greg Knoblanche, Anthony Delaney, "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", Anesthesiology Research and Practice, vol. 2022, Article ID 4659795, 8 pages, 2022.	https://doi.org/10.1155/2022/4659795

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2022	https://dx.doi.org/10.1155/2022/4659795

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically