Evidence map›Paper›PMID 25187755›Full record

Trial reportBMC anesthesiology2014

Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects.

Xinmin Wu, Helle Oerding, Jin Liu, Bernard Vanacker, Shanglong Yao, Vegard Dahl, Lize Xiong, Casper Claudius, Yun Yue, Yuguang Huang and 3 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC anesthesiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00825812 (A Multi-center, Randomized, Parallel-group, Active-controlled, Safety-assessor Blinded Trial, Comparing the Efficacy and Safety of 2.0 mg.Kg-1 Sugammadex With 50 μg.Kg-1 Neostigmine Administered at Reappearance of T2 After Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 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.

NCT00825812 phase3completednot on this map

A Multi-center, Randomized, Parallel-group, Active-controlled, Safety-assessor Blinded Trial, Comparing the Efficacy and Safety of 2.0 mg.Kg-1 Sugammadex With 50 μg.Kg-1 Neostigmine Administered at Reappearance of T2 After Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2010 to 2010Enrolled308ConditionsAnesthesia, General, Neuromuscular BlockadeArmsSugammadex, neostigmine
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

13 authors.

Xinmin WuPeking University First Hospital, No 8 Xishiku St, Beijing 100034, China.
Helle OerdingDepartment of Anaesthesiology, Vejle Hospital, Vejle, Denmark.
Jin LiuWest China Hospital, Sichuan University, Chengdu, China.
Bernard VanackerDepartment of Anesthesiology, University Hospitals Leuven, Leuven, Belgium.
Shanglong YaoUnion Hospital, Tongji Medical College, Wuhan, China.
Vegard DahlAnaesthesia and Intensive Care, Asker and Baerum Hospital, Oslo, Norway.
Lize XiongDepartment of Anesthesiology, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.
Casper ClaudiusDepartment of Anaesthesia, Hillerød Hospital, Hillerød, Denmark.
Yun YueBeijing Chaoyang Hospital, Beijing, China.
Yuguang HuangPeking Union Medical College Hospital, Beijing, China.
Esther AbelsMSD, Oss, The Netherlands.
Henk RietbergenMSD, Oss, The Netherlands.
Tiffany WooMerck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study compared efficacy and safety of the selective relaxant binding agent sugammadex (2 mg/kg) with neostigmine (50 μg/kg) for neuromuscular blockade (NMB) reversal in Chinese and Caucasian subjects.

methodsThis was a randomized, active-controlled, multicenter, safety-assessor-blinded study (NCT00825812) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia. Rocuronium 0.6 mg/kg was administered for endotracheal intubation, with 0.1-0.2 mg/kg maintenance doses given as required. NMB was monitored using TOF-Watch(®) SX. At second twitch reappearance, after last rocuronium dose, subjects received sugammadex 2 mg/kg or neostigmine 50 μg/kg plus atropine 10-20 μg/kg, according to randomization. Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four (TOF) ratio to 0.9.

resultsOverall, 230 Chinese subjects (sugammadex, n = 119, neostigmine, n = 111); and 59 Caucasian subjects (sugammadex, n = 29, neostigmine, n = 30) had evaluable data. Geometric mean (95% CI) time to recovery to TOF ratio 0.9 was 1.6 (1.5-1.7) min with sugammadex vs 9.1 (8.0-10.3) min with neostigmine in Chinese subjects. Corresponding times for Caucasian subjects were 1.4 (1.3-1.5) min and 6.7 (5.5-8.0) min, respectively. Sugammadex 2 mg/kg was generally well tolerated, with no serious adverse events reported. There was no residual NMB or recurrence of NMB.

conclusionBoth Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2 mg/kg vs neostigmine 50 μg/kg, with a ~5.7 times (p < 0.0001) faster recovery with sugammadex vs neostigmine in Chinese subjects. Sugammadex was generally well tolerated.

trial registrationClinicalTrials.gov Identifier: NCT00825812.

Indexed as

AdultAgedAndrostanolsAsian PeopleFemalegamma-CyclodextrinsHumansMaleMiddle AgedNeostigmineNeuromuscular BlockadeNeuromuscular Nondepolarizing AgentsParasympathomimeticsRocuroniumSugammadexTreatment OutcomeAndrostanolsgamma-CyclodextrinsNeostigmineNeuromuscular Nondepolarizing AgentsParasympathomimeticsRocuroniumSugammadexCaucasianChineseNeostigmineNeuromuscular blockadeRocuroniumSugammadex

Identifiers

PMID25187755
PMCPMC4153006

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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.