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Org 25969 (sugammadex), a selective relaxant binding agent for antagonism of prolonged rocuronium-induced neuromuscular block.
Br J Anaesth. 2006 Jan; 96(1):36-43.BJ

Abstract

BACKGROUND

Org 25969 is a cyclodextrin compound designed to reverse a rocuronium-induced neuromuscular block. The aim of this study was to explore the efficacy, dose-response relation and safety of Org 25969 for reversal of a prolonged rocuronium-induced neuromuscular block.

METHODS

Thirty anaesthetized adult patients received rocuronium 0.6 mg kg(-1) as an initial dose followed by increments to maintain a deep block at a level of <10 PTCs (post-tetanic counts) recorded every 6 min. Neuromuscular monitoring was carried out using accelerometry, in a train-of-four (TOF) mode using TOF-WatchSX. At recovery of T2, following at least 2 h of neuromuscular block, patients received their randomly assigned dose of 0.5, 1.0, 2.0, 4.0 or 6.0 mg kg(-1) of Org 25969. Anaesthesia and neuromuscular monitoring were continued for a minimum period of 30 min after Org 25969 administration. The main end-point of the study was the time to achieve a sustained recovery of TOF ratio to 0.9. Patients were followed up for 7 days after anaesthesia.

RESULTS

The results showed a dose-related decrease in the average time taken to attain a TOF ratio of 0.9 from 6:49 (min:s) with the 0.5 mg kg(-1) dose to 1:22 with the 4.0 mg kg(-1) dose. Weighted non-linear regression analysis showed the fastest achievable time to TOF ratio of 0.9 to be 1:35. Org 25969 produced no major adverse effects.

CONCLUSION

Org 25969 effectively reversed a deep and prolonged neuromuscular block induced by rocuronium. The effective reversal dose appears to be 2-4 mg kg(-1).

Authors+Show Affiliations

Department of Anaesthetics and Intensive Care Medicine, Queen's University of Belfast, Northern Ireland, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16357116

Citation

Shields, M, et al. "Org 25969 (sugammadex), a Selective Relaxant Binding Agent for Antagonism of Prolonged Rocuronium-induced Neuromuscular Block." British Journal of Anaesthesia, vol. 96, no. 1, 2006, pp. 36-43.
Shields M, Giovannelli M, Mirakhur RK, et al. Org 25969 (sugammadex), a selective relaxant binding agent for antagonism of prolonged rocuronium-induced neuromuscular block. Br J Anaesth. 2006;96(1):36-43.
Shields, M., Giovannelli, M., Mirakhur, R. K., Moppett, I., Adams, J., & Hermens, Y. (2006). Org 25969 (sugammadex), a selective relaxant binding agent for antagonism of prolonged rocuronium-induced neuromuscular block. British Journal of Anaesthesia, 96(1), 36-43.
Shields M, et al. Org 25969 (sugammadex), a Selective Relaxant Binding Agent for Antagonism of Prolonged Rocuronium-induced Neuromuscular Block. Br J Anaesth. 2006;96(1):36-43. PubMed PMID: 16357116.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Org 25969 (sugammadex), a selective relaxant binding agent for antagonism of prolonged rocuronium-induced neuromuscular block. AU - Shields,M, AU - Giovannelli,M, AU - Mirakhur,R K, AU - Moppett,I, AU - Adams,J, AU - Hermens,Y, PY - 2005/12/17/pubmed PY - 2006/1/31/medline PY - 2005/12/17/entrez SP - 36 EP - 43 JF - British journal of anaesthesia JO - Br J Anaesth VL - 96 IS - 1 N2 - BACKGROUND: Org 25969 is a cyclodextrin compound designed to reverse a rocuronium-induced neuromuscular block. The aim of this study was to explore the efficacy, dose-response relation and safety of Org 25969 for reversal of a prolonged rocuronium-induced neuromuscular block. METHODS: Thirty anaesthetized adult patients received rocuronium 0.6 mg kg(-1) as an initial dose followed by increments to maintain a deep block at a level of <10 PTCs (post-tetanic counts) recorded every 6 min. Neuromuscular monitoring was carried out using accelerometry, in a train-of-four (TOF) mode using TOF-WatchSX. At recovery of T2, following at least 2 h of neuromuscular block, patients received their randomly assigned dose of 0.5, 1.0, 2.0, 4.0 or 6.0 mg kg(-1) of Org 25969. Anaesthesia and neuromuscular monitoring were continued for a minimum period of 30 min after Org 25969 administration. The main end-point of the study was the time to achieve a sustained recovery of TOF ratio to 0.9. Patients were followed up for 7 days after anaesthesia. RESULTS: The results showed a dose-related decrease in the average time taken to attain a TOF ratio of 0.9 from 6:49 (min:s) with the 0.5 mg kg(-1) dose to 1:22 with the 4.0 mg kg(-1) dose. Weighted non-linear regression analysis showed the fastest achievable time to TOF ratio of 0.9 to be 1:35. Org 25969 produced no major adverse effects. CONCLUSION: Org 25969 effectively reversed a deep and prolonged neuromuscular block induced by rocuronium. The effective reversal dose appears to be 2-4 mg kg(-1). SN - 0007-0912 UR - https://www.unboundmedicine.com/medline/citation/16357116/Org_25969__sugammadex__a_selective_relaxant_binding_agent_for_antagonism_of_prolonged_rocuronium_induced_neuromuscular_block_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0007-0912(17)35260-1 DB - PRIME DP - Unbound Medicine ER -