Evidence map›Paper›PMID 34711192›Full record

Trial reportBMC anesthesiology2021

A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants.

W Joseph Herring, Yuki Mukai, Aobo Wang, Jeannine Lutkiewicz, John F Lombard, Li Lin, Molly Watkins, David M Broussard, Manfred Blobner

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC anesthesiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03346057 (A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 15% of its field
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.

NCT03346057 phase4completednot on this map

A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (ASA) Class 3 or 4 Subjects

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2019Enrolled344ConditionsReversal of Neuromuscular BlockadeArmsSugammadex 2 mg/kg, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg, Neostigmine + Glycopyrrolate, Rocuronium
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Observational
  6. Article
  7. Article
  8. Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials.Current research in pharmacology and drug discovery · 2025
    Review
  9. Observational
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

9 authors at 3 institutions in 2 countries.

W Joseph HerringDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. william.herring@merck.com.
Yuki MukaiDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
Aobo WangDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
Jeannine LutkiewiczDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
John F LombardDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
Li LinDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
Molly WatkinsDepartment of Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
David M Broussard *Ochsner Clinic Foundation, New Orleans, LA, USA.
Manfred Blobner *Department of Anesthesiology and Intensive Care Medicine, School of Medicine, Technical University of Munich, Munich, Germany.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USOchsner Medical Center · USUniversität Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this randomized, double-blind trial was to evaluate the safety and tolerability profile, including cardiac safety, of sugammadex-mediated recovery from neuromuscular block in participants undergoing surgery who met the American Society of Anesthesiologists (ASA) Physical Class 3 or 4 criteria. Specifically, this study assessed the impact of sugammadex on cardiac adverse events (AEs) and other prespecified AEs of clinical interest.

methodsParticipants meeting ASA Class 3 and 4 criteria were stratified by ASA Class and NMBA (rocuronium or vecuronium) then randomized to one of the following: 1) Moderate neuromuscular block, sugammadex 2 mg/kg; 2) Moderate neuromuscular block, neostigmine and glycopyrrolate (neostigmine/glycopyrrolate); 3) Deep neuromuscular block, sugammadex 4 mg/kg; 4) Deep neuromuscular block, sugammadex 16 mg/kg (rocuronium only). Primary endpoints included incidences of treatment-emergent (TE) sinus bradycardia, TE sinus tachycardia and other TE cardiac arrhythmias.

resultsOf 344 participants randomized, 331 received treatment (61% male, BMI 28.5 ± 5.3 kg/m

conclusionsCompared with neostigmine/glycopyrrolate, incidence of TE sinus bradycardia was significantly lower with sugammadex 2 mg/kg and incidence of TE sinus tachycardia was significantly lower with sugammadex 2 mg/kg and 4 mg/kg. These results support the safety of sugammadex for reversing rocuronium- or vecuronium-induced moderate and deep neuromuscular block in ASA Class 3 or 4 participants.

trial registrationClinicalTrials.gov Identifier: NCT03346057 .

Indexed as

Neuromuscular BlockadeAgedBradycardiaCholinergic AgentsDouble-Blind MethodFemaleGlycopyrrolateHumansMaleNeostigmineNeuromuscular Nondepolarizing AgentsRocuroniumSugammadexTachycardiaVecuronium BromideCholinergic AgentsGlycopyrrolateNeostigmineNeuromuscular Nondepolarizing AgentsRocuroniumSugammadexVecuronium BromideASA physical class 3 or 4Sugammadex: safety

Identifiers

PMID34711192
PMCPMC8555093
OpenAlexW3208337973

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.