Abstract | STUDY OBJECTIVE: DESIGN: Phase III, randomized, multicenter, parallel-group, comparative, safety-assessor blinded study. SETTING: Nine hospital sites. PATIENTS: 77 ASA physical status 2 and 3 patients, aged ≥ 18 years, with a history of pulmonary disease, and scheduled for surgery with general anesthesia requiring neuromuscular blockade. INTERVENTIONS: Following anesthesia induction, patients received rocuronium 0.6 mg/kg with 0.15 mg/kg maintenance doses as needed. Patients were randomized to receive sugammadex 2 mg/kg or 4 mg/kg after the last rocuronium dose at reappearance of the second twitch. MEASUREMENTS: Safety evaluations included adverse events, laboratory parameters, vital signs, and evidence of recurrent or residual neuromuscular blockade. Efficacy was evaluated as the time from sugammadex administration to recovery of the train-of-four (TOF) ratio to ≥ 0.9. MAIN RESULTS: Safety was comparable between doses, with no evidence of residual or recurrent neuromuscular blockade. Two bronchospasm cases were reported (4 mg/kg group), both in patients with asthma who received desflurane for anesthesia maintenance. Geometric mean (95% confidence interval) times to a TOF ratio of ≥ 0.9 were 2.1 (1.7 - 3.1) min (2 mg/kg) and 1.8 (1.5 - 2.7) min (4 mg/kg). CONCLUSION:
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Authors | Rasheed Amao, Mark H Zornow, Robert McTaggart Cowan, Davy C Cheng, Jovino B Morte, Martin W Allard |
Journal | Journal of clinical anesthesia
(J Clin Anesth)
Vol. 24
Issue 4
Pg. 289-97
(Jun 2012)
ISSN: 1873-4529 [Electronic] United States |
PMID | 22608583
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 Elsevier Inc. All rights reserved. |
Chemical References |
- Androstanols
- Neuromuscular Nondepolarizing Agents
- gamma-Cyclodextrins
- Sugammadex
- Rocuronium
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Topics |
- Adult
- Aged
- Androstanols
(antagonists & inhibitors)
- Anesthesia Recovery Period
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Lung Diseases
(complications)
- Male
- Middle Aged
- Neuromuscular Blockade
(methods)
- Neuromuscular Junction
(drug effects, physiology)
- Neuromuscular Nondepolarizing Agents
(antagonists & inhibitors)
- Postoperative Care
(methods)
- Rocuronium
- Sugammadex
- gamma-Cyclodextrins
(administration & dosage, adverse effects, pharmacology)
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