PMID- 18238834
OWN - NLM
STAT- MEDLINE
DCOM- 20080324
LR  - 20220330
IS  - 1471-6771 (Electronic)
IS  - 0007-0912 (Linking)
VI  - 100
IP  - 3
DP  - 2008 Mar
TI  - Safety and tolerability of single intravenous doses of sugammadex administered 
      simultaneously with rocuronium or vecuronium in healthy volunteers.
PG  - 373-9
LID - 10.1093/bja/aem402 [doi]
AB  - BACKGROUND: Sugammadex rapidly reverses rocuronium- and vecuronium-induced 
      neuromuscular block. To investigate the effect of combination of sugammadex and 
      rocuronium or vecuronium on QT interval, it would be preferable to avoid the 
      interference of anaesthesia. Therefore, this pilot study was performed to 
      investigate the safety, tolerability, and plasma pharmacokinetics of single i.v. 
      doses of sugammadex administered simultaneously with rocuronium or vecuronium to 
      anaesthetized and non-anaesthetized healthy volunteers. METHODS: In this phase I 
      study, 12 subjects were anaesthetized with propofol/remifentanil and received 
      sugammadex 16, 20, or 32 mg kg(-1) combined with rocuronium 1.2 mg kg(-1) or 
      vecuronium 0.1 mg kg(-1); four subjects were not anaesthetized and received 
      sugammadex 32 mg kg(-1) with rocuronium 1.2 mg kg(-1) or vecuronium 0.1 mg kg(-1) 
      (n=2 per treatment). Neuromuscular function was assessed by TOF-Watch SX 
      monitoring in anaesthetized subjects and by clinical tests in non-anaesthetized 
      volunteers. Sugammadex, rocuronium, and vecuronium plasma concentrations were 
      measured at several time points. RESULTS: No serious adverse events (AEs) were 
      reported. Fourteen subjects reported 23 AEs after study drug administration. 
      Episodes of mild headache, tiredness, cold feeling (application site), dry mouth, 
      oral discomfort, nausea, increased aspartate aminotransferase and 
      gamma-glutamyltransferase levels, and moderate injection site irritation were 
      considered as possibly related to the study drug. The ECG and vital signs showed 
      no clinically relevant changes. Rocuronium/vecuronium plasma concentrations 
      declined faster than those of sugammadex. CONCLUSIONS: Single-dose administration 
      of sugammadex 16, 20, or 32 mg kg(-1) in combination with rocuronium 1.2 mg 
      kg(-1) or vecuronium 0.1 mg kg(-1) was well tolerated with no clinical evidence 
      of residual neuromuscular block, confirming that these combinations can safely be 
      administered simultaneously to non-anaesthetized subjects. Rocuronium and 
      vecuronium plasma concentrations decreased faster than those of sugammadex, 
      reducing the theoretical risk of neuromuscular block developing over time.
FAU - Cammu, G
AU  - Cammu G
AD  - Department of Anaesthesiology and Critical Care Medicine, Onze Lieve Vrouw 
      Clinic, Moorselbaan 164, 9300 Aalst, Belgium. guy.cammu@olvz-aalst.be
FAU - De Kam, P J
AU  - De Kam PJ
FAU - Demeyer, I
AU  - Demeyer I
FAU - Decoopman, M
AU  - Decoopman M
FAU - Peeters, P A M
AU  - Peeters PA
FAU - Smeets, J M W
AU  - Smeets JM
FAU - Foubert, L
AU  - Foubert L
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20080131
PL  - England
TA  - Br J Anaesth
JT  - British journal of anaesthesia
JID - 0372541
RN  - 0 (Androstanols)
RN  - 0 (Anesthetics, Intravenous)
RN  - 0 (Neuromuscular Nondepolarizing Agents)
RN  - 0 (gamma-Cyclodextrins)
RN  - 361LPM2T56 (Sugammadex)
RN  - 7E4PHP5N1D (Vecuronium Bromide)
RN  - WRE554RFEZ (Rocuronium)
RN  - YI7VU623SF (Propofol)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Androstanols/administration & dosage/*antagonists & inhibitors/blood
MH  - Anesthetics, Intravenous
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Neuromuscular Blockade
MH  - Neuromuscular Junction/drug effects/physiology
MH  - Neuromuscular Nondepolarizing Agents/administration & dosage/*antagonists & 
      inhibitors/blood
MH  - Propofol
MH  - Rocuronium
MH  - Sugammadex
MH  - Vecuronium Bromide/administration & dosage/*antagonists & inhibitors/blood
MH  - gamma-Cyclodextrins/administration & dosage/*adverse effects/blood/pharmacology
EDAT- 2008/02/02 09:00
MHDA- 2008/03/25 09:00
CRDT- 2008/02/02 09:00
PHST- 2008/02/02 09:00 [pubmed]
PHST- 2008/03/25 09:00 [medline]
PHST- 2008/02/02 09:00 [entrez]
AID - S0007-0912(17)34660-3 [pii]
AID - 10.1093/bja/aem402 [doi]
PST - ppublish
SO  - Br J Anaesth. 2008 Mar;100(3):373-9. doi: 10.1093/bja/aem402. Epub 2008 Jan 31.