Abstract | BACKGROUND: METHODS: Two hundred forty-five patients scheduled for coronary artery bypass surgery were recruited at two centers and prospectively randomized to clomethiazole edisilate (0.8%), 225 ml (1.8 mg) loading dose followed by a maintenance dose of 100 ml/h (0.8 mg/h) during surgery, or 0.9% NaCl (placebo) in a double-blind trial. Coronary artery grafting was completed during moderate hypothermic (28-32 degrees C) cardiopulmonary bypass. Plasma clomethiazole was measured at several intervals during and up to 24 h after the end of infusion. A battery of eight neuropsychological tests was administered preoperatively and repeated 4-7 weeks after surgery. Analysis of the change in neuropsychological test scores from baseline was used to determine the effect of treatment. RESULTS: Neuropsychological assessments were completed in 219 patients (110 clomethiazole; 109 placebo). The mean plasma concentration of clomethiazole during surgery was 66.2 microm. There was no difference between the clomethiazole and placebo group in the postoperative change in neuropsychological test scores. CONCLUSION:
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Authors | Robert S Kong, John Butterworth, Wynne Aveling, David A Stump, Michael J G Harrison, John Hammon, Jan Stygall, Kashemi D Rorie, Stanton P Newman |
Journal | Anesthesiology
(Anesthesiology)
Vol. 97
Issue 3
Pg. 585-91
(Sep 2002)
ISSN: 0003-3022 [Print] United States |
PMID | 12218524
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Neuroprotective Agents
- Chlormethiazole
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Topics |
- Affect
(drug effects)
- Aged
- Chlormethiazole
(administration & dosage, blood, therapeutic use)
- Coronary Artery Bypass
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Infusions, Intravenous
- Intracranial Embolism and Thrombosis
(prevention & control)
- Male
- Middle Aged
- Neuroprotective Agents
(administration & dosage, blood, therapeutic use)
- Neuropsychological Tests
- Postoperative Complications
(drug therapy, psychology)
- Prospective Studies
- Treatment Outcome
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