Evidence map›Paper›PMID 34753515›Full record

ArticlePilot and feasibility studies2021

Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial.

Kate Leslie, Matthew T V Chan, Jai N Darvall, Anurika P De Silva, Sabine Braat, Nancy J Devlin, Philip J Peyton, Jade Radnor, Carmen K M Lam, Sofia Sidiropoulos and 1 more

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Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kate LeslieDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia. kate.leslie@mh.org.au.ORCID http://orcid.org/0000-0001-8512-3517
Matthew T V ChanDepartment of Anaesthesia and Intensive Care, Chinese University of Hong Kong, The Prince of Wales Hospital, Hong Kong Special Administrative Region, People's Republic of China.
Jai N DarvallDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.
Anurika P De SilvaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Sabine BraatCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Nancy J DevlinHealth Economics Unit, Melbourne School of Population and Global Health, Melbourne, Australia.
Philip J PeytonDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.
Jade RadnorDepartment of Anaesthesia and Pain Management, Northeast Health Wangaratta, Wangaratta, Australia.
Carmen K M LamDepartment of Anaesthesia and Operating Room Services, Tuen Mun Hospital, Hong Kong Special Administrative Region, People's Republic of China.
Sofia SidiropoulosDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.
David A StoryDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.

Funding

Australian and New Zealand College of Anaesthetists Pilot Grant Scheme 2020
6 · The paper itself

Abstract

backgroundSugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications.

methodsPatients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital).

resultsAmong 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5-4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67).

conclusionsA large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible.

trial registrationProspectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .

Indexed as

AtelectasisNeostigmineNeuromuscular blockadePneumoniaSugammadex

Identifiers

PMID34753515
PMCPMC8576081

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.