NCT02825576

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
2.4 years until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

June 21, 2016

Last Update Submit

March 27, 2023

Conditions

Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to day 2 post operatively.

Secondary Outcomes (5)

  • Quality of Recovery Score (QoR-15)

    Day 1 and Day 30 post operatively

  • Incidence of post operative nausea and vomiting.

    Day of surgery.

  • Incidence of airway events in the Post Anaesthesia Care Unit (PACU).

    Day of surgery.

  • Mortality

    30 day

  • Hospital stay

    30 days

Study Arms (2)

Sugammadex group

ACTIVE COMPARATOR

Sugammadex 2mg/kg intravenously at completion of surgery.

Drug: Sugammadex

Neostigmine/Glycopyrrolate group

ACTIVE COMPARATOR

Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery.

Drug: Neostigmine/Glycopyrrolate

Interventions

SugammadexDRUG

Sugammadex 2mg/kg given for reversal agent

Also known as: Bridion
Sugammadex group
Neostigmine/GlycopyrrolateDRUG

Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent

Neostigmine/Glycopyrrolate group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (1)

  • 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.

    PMID: 35844810RESULT

MeSH Terms

Interventions

SugammadexNeostigmineGlycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ben L Olesnicky, BMBS BSc

    Northern Sydney Anaesthesia Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 7, 2016

Study Start

December 3, 2018

Primary Completion

April 1, 2020

Study Completion

January 1, 2021

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Locations

AU(1)