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

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000063415

Acronym

P-PERSoN

Enrollment

Registered

2016-01-21

Start date

2018-12-03

Completion date

2019-01-01

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

2mg/kg intravenous sugammadex at completion of surgery

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results