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Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery.
Anaesthesist. 2015 Jul; 64(7):506-12.A

Abstract

BACKGROUND

Deep neuromuscular blockade (NMB) may not always be maintained to the end of surgery and the depth of block may be allowed to gradually diminish over time, particularly if reversal of NMB is not routinely performed.

AIM

The current study aimed to assess recovery from deep rocuronium-induced NMB with sugammadex compared with placebo, provide data regarding the extent of residual blockade after deep rocuronium-induced NMB (placebo group), and to determine whether complete and reliable recovery could be provided by sugammadex (sugammadex group).

MATERIALS AND METHODS

This was a randomized, placebo-controlled, safety-assessor-blinded study in adult patients of American Society of Anesthesiologists Class I to III. Patients with clinically relevant kidney or liver insufficiency were excluded. Anesthesia was administered as routinely practiced at each study site. Rocuronium 0.6 mg/kg was administered for intubation, with maintenance doses of 0.1-0.2 mg/kg as needed. After the last rocuronium dose, at deep NMB (target depth 1-2 post-tetanic counts), patients received a single dose of sugammadex 4.0 mg/kg or placebo as randomized. The primary endpoint was time from sugammadex or placebo administration to recovery of the train-of-four (TOF) ratio to 0.9. Safety was assessed through monitoring of adverse events, vital signs and physical examination. Patients were also assessed for evidence of residual or recurrence of NMB. With this design, the study will provide data regarding the extent of residual blockade under these conditions (placebo group), and determine whether complete and reliable recovery could be provided by sugammadex (sugammadex group).

RESULTS

Recovery to a TOF ratio of ≥ 0.9 with sugammadex was significantly faster (~ 40 times) than spontaneous recovery: geometric mean (95 % confidence interval) times were 2.2 (1.9-2.5) and 89.8 (80.1-100.7) min, respectively (p < 0.0001, N = 134); maximum spontaneous recovery was 289.8 min. Safety was comparable between groups, with no recurrence of blockade.

CONCLUSIONS

This study confirms a prolonged residual blockade in patients who did not receive sugammadex, with median time to recovery > 1.5 h in the placebo group and one patient taking 4.8 h to achieve a safe level of neuromuscular function recovery following deep NMB. In contrast, sugammadex provided complete and reliable recovery of neuromuscular function (median time to recovery of 2.0 min). Thus, deep NMB with rocuronium until the end of the operation may be possible in combination with sugammadex reversal.

Authors+Show Affiliations

Department of Anaesthesiology and Intensive Care, Franziskus Hospital, Kiskerstr. 26, 33615, Bielefeld, Germany, Niels.Rahe-Meyer@Franziskus.de.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26126940

Citation

Rahe-Meyer, N, et al. "Recovery From Prolonged Deep Rocuronium-induced Neuromuscular Blockade: a Randomized Comparison of Sugammadex Reversal With Spontaneous Recovery." Der Anaesthesist, vol. 64, no. 7, 2015, pp. 506-12.
Rahe-Meyer N, Berger C, Wittmann M, et al. Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery. Anaesthesist. 2015;64(7):506-12.
Rahe-Meyer, N., Berger, C., Wittmann, M., Solomon, C., Abels, E. A., Rietbergen, H., & Reuter, D. A. (2015). Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery. Der Anaesthesist, 64(7), 506-12. https://doi.org/10.1007/s00101-015-0048-0
Rahe-Meyer N, et al. Recovery From Prolonged Deep Rocuronium-induced Neuromuscular Blockade: a Randomized Comparison of Sugammadex Reversal With Spontaneous Recovery. Anaesthesist. 2015;64(7):506-12. PubMed PMID: 26126940.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery. AU - Rahe-Meyer,N, AU - Berger,C, AU - Wittmann,M, AU - Solomon,C, AU - Abels,E A M, AU - Rietbergen,H, AU - Reuter,D A, Y1 - 2015/07/01/ PY - 2014/08/13/received PY - 2015/05/15/accepted PY - 2015/05/12/revised PY - 2015/7/2/entrez PY - 2015/7/2/pubmed PY - 2016/4/20/medline SP - 506 EP - 12 JF - Der Anaesthesist JO - Anaesthesist VL - 64 IS - 7 N2 - BACKGROUND: Deep neuromuscular blockade (NMB) may not always be maintained to the end of surgery and the depth of block may be allowed to gradually diminish over time, particularly if reversal of NMB is not routinely performed. AIM: The current study aimed to assess recovery from deep rocuronium-induced NMB with sugammadex compared with placebo, provide data regarding the extent of residual blockade after deep rocuronium-induced NMB (placebo group), and to determine whether complete and reliable recovery could be provided by sugammadex (sugammadex group). MATERIALS AND METHODS: This was a randomized, placebo-controlled, safety-assessor-blinded study in adult patients of American Society of Anesthesiologists Class I to III. Patients with clinically relevant kidney or liver insufficiency were excluded. Anesthesia was administered as routinely practiced at each study site. Rocuronium 0.6 mg/kg was administered for intubation, with maintenance doses of 0.1-0.2 mg/kg as needed. After the last rocuronium dose, at deep NMB (target depth 1-2 post-tetanic counts), patients received a single dose of sugammadex 4.0 mg/kg or placebo as randomized. The primary endpoint was time from sugammadex or placebo administration to recovery of the train-of-four (TOF) ratio to 0.9. Safety was assessed through monitoring of adverse events, vital signs and physical examination. Patients were also assessed for evidence of residual or recurrence of NMB. With this design, the study will provide data regarding the extent of residual blockade under these conditions (placebo group), and determine whether complete and reliable recovery could be provided by sugammadex (sugammadex group). RESULTS: Recovery to a TOF ratio of ≥ 0.9 with sugammadex was significantly faster (~ 40 times) than spontaneous recovery: geometric mean (95 % confidence interval) times were 2.2 (1.9-2.5) and 89.8 (80.1-100.7) min, respectively (p < 0.0001, N = 134); maximum spontaneous recovery was 289.8 min. Safety was comparable between groups, with no recurrence of blockade. CONCLUSIONS: This study confirms a prolonged residual blockade in patients who did not receive sugammadex, with median time to recovery > 1.5 h in the placebo group and one patient taking 4.8 h to achieve a safe level of neuromuscular function recovery following deep NMB. In contrast, sugammadex provided complete and reliable recovery of neuromuscular function (median time to recovery of 2.0 min). Thus, deep NMB with rocuronium until the end of the operation may be possible in combination with sugammadex reversal. SN - 1432-055X UR - https://www.unboundmedicine.com/medline/citation/26126940/Recovery_from_prolonged_deep_rocuronium_induced_neuromuscular_blockade:_A_randomized_comparison_of_sugammadex_reversal_with_spontaneous_recovery_ L2 - https://dx.doi.org/10.1007/s00101-015-0048-0 DB - PRIME DP - Unbound Medicine ER -