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The influence of mild hypothermia on reversal of rocuronium-induced deep neuromuscular block with sugammadex.

ABSTRACT: Mild hypothermia may be frequently induced due to cool environments in the operating room. The study analyzed patient recovery time and response to sugammadex after a prolonged rocuronium-induced deep neuromuscular block (NMB) during mild hypothermia.Sixty patients were randomly (1:1) allocated to the mild hypothermia and normothermia groups, defined as having core temperatures between 34.5-35°C and 36.5-37°C, respectively. Patients received 0.6 mg/kg of rocuronium, followed by 7-10 ?g/kg/min to maintain a deep NMB [post-tetanic count (PTC) 1-2]. After surgery, the deep NMB was reversed with sugammadex 4.0 mg/kg. The primary end-point was the time until the train-of-four (TOF) ratio was 0.9.The appropriate neuromuscular function (TOF ratio???0.9) was restored after sugammadex was administered, even after hypothermia. The length of recovery in the hypothermia patients [mean (SD), 171.1 (62.1) seconds (s)] was significantly slower compared with the normothermia patients [124.9 (59.2) s] (p?=?0.005). There were no adverse effects from sugammadex.Sugammadex safely and securely reversed deep rocuronium-induced NMB during mild hypothermia. An additional 46 s was required for recovery from a deep NMB in hypothermia patients. Based on the results, we think this prolonged recovery time is clinically acceptable.ClinicalTrials.gov Identifier: NCT01965067.

SUBMITTER: Lee HJ

PROVIDER: S-EPMC4430027 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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The influence of mild hypothermia on reversal of rocuronium-induced deep neuromuscular block with sugammadex.

Lee Hee Jong HJ Kim Kyo Sang KS Jeong Ji Seon JS Kim Kyu Nam KN Lee Byeong Chan BC

BMC anesthesiology 20150121

<h4>Background</h4>Mild hypothermia may be frequently induced due to cool environments in the operating room. The study analyzed patient recovery time and response to sugammadex after a prolonged rocuronium-induced deep neuromuscular block (NMB) during mild hypothermia.<h4>Methods</h4>Sixty patients were randomly (1:1) allocated to the mild hypothermia and normothermia groups, defined as having core temperatures between 34.5-35°C and 36.5-37°C, respectively. Patients received 0.6 mg/kg of rocuro ...[more]

PMID: 25971394

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Project description:Background: Sugammadex is known to reverse neuromuscular blockade induced by non-depolarizing agents. In children, the recommended dose for reversal of moderate neuromuscular blockade is 2 mg/kg. We investigated the pharmacokinetics and pharmacodynamics of sugammadex in Korean children. Methods: Children (2-17 years of age) undergoing brain or spine surgery were enrolled and randomly assigned to control (neostigmine) and 2, 4, or 8 mg/kg sugammadex groups. Following induction of anesthesia and monitoring of the response to train-of-four stimulation, 1 mg/kg rocuronium was intravenously administered. Upon reappearance of the second twitch to train-of-four stimulation, the study drug was administered according to group allocation. The plasma concentrations of rocuronium and sugammadex were serially measured at nine predefined time points following study drug administration. To determine efficacy, we measured the time elapsed from drug administration to recovery of T4/T1 ≥ 0.9. For pharmacokinetics, non-compartmental analysis was performed and we monitored adverse event occurrence from the time of study drug administration until 24 h post-surgery. Results: Among the 29 enrolled participants, the sugammadex (2 mg/kg) and control groups showed recovery times [median (interquartile range)] of 1.3 (1.0-1.9) and 7.7 (5.3-21.0) min, respectively (p = 0.002). There were no significant differences in recovery time among the participants in sugammadex groups. The pharmacokinetics of sugammadex were comparable to those of literature findings. Although two hypotensive events related to sugammadex were observed, no intervention was necessary. Conclusion: The findings of this pharmacokinetic analysis and efficacy study of sugammadex in Korean children indicated that sugammadex (2 mg/kg) may be safely administered for reversing moderate neuromuscular blockade. Some differences in pharmacokinetics of sugammadex were observed according to age. Clinical Trial Registration: http://clinicaltrials.gov (NCT04347486).

Dataset Information

The influence of mild hypothermia on reversal of rocuronium-induced deep neuromuscular block with sugammadex.

Publications

The influence of mild hypothermia on reversal of rocuronium-induced deep neuromuscular block with sugammadex.

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