PubMed · 4386326
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R I Bodman. 1967. Controlled hypotension.. https://doi.org/10.1097/00004311-196700510-00005
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STUDY OBJECTIVES: To evaluate and compare the efficacy and safety of three doses of sodium oxybate and placebo for the treatment of narcolepsy symptoms. DESIGN: A multicenter, double blind, placebo-controlled trial. SETTING: N/A. PARTICIPANTS: Study subjects were 136 narcolepsy patients with 3 to 249 (median 21) cataplexy attacks weekly. INTERVENTIONS: Prior to baseline measures, subjects discontinued anticataplectic medications. Stable doses of stimulants were permitted. Subjects were randomized in blinded fashion to receive 3, 6, or 9 g doses of sodium oxybate or placebo taken in equally divided doses upon retiring to bed and 2.5-4 hours later for 4 weeks. MEASUREMENTS AND RESULTS: Disease symptoms and adverse events were recorded in daily diaries. The primary measure of efficacy was the change from baseline in weekly cataplexy attacks. Secondary measures included daytime sleepiness using the Epworth Sleepiness Scale (ESS), inadvertent daytime naps/sleep attacks and nighttime awakenings. Investigators assessed changes in disease severity using Clinical Global Impression of Change (CGI-c). Compared to placebo, weekly cataplexy attacks were decreased by sodium oxybate at the 6 g dose (p=0.0529) and significantly at the 9 g dose (p=0.0008). The ESS was reduced at all doses, becoming significant at the 9 g dose (p=0.0001). The CGI-c demonstrated a dose-related improvement, significant at the 9 g dose (p=0.0002). The frequency of inadvertent naps/sleep attacks and the nighttime awakenings showed similar dose-response trends, becoming significant at the 9 g dose (p=0.0122 and p=0.0035, respectively). Sodium oxybate was generally well-tolerated at all three doses. Nausea, headache, dizziness and enuresis were the most commonly reported adverse events. CONCLUSIONS: Sodium oxybate significantly improved symptoms in patients with narcolepsy and was well tolerated.
The object of this study was to investigate the influence of midazolam on the plasma concentrations and pharmacokinetic parameters of lidocaine in rabbits. Lidocaine levels were determined by the immunofluorescence polarization method, using Abbott reagents. After intravenous administration of a combined dose of midazolam (0.2 mg kg(-1)i.v.) with lidocaine (1 mg kg(-1)i.v.) a statistically perceivable decrease of lidocaine concentration, together with an increase of the constant rate of its elimination and reduction of the biological half-life with average time of lidocaine remaining in the system were observed. Midazolam administered intravenously together with lidocaine shortens the residence time of the drug.
PURPOSE: To review the use of adjuncts to intravenous regional anesthesia (IVRA) for surgical procedures in terms of their intraoperative effects (efficacy of block and tourniquet pain) and postoperative analgesia. SOURCE: A systematic search (Medline, Embase, reference lists) for randomized, controlled and double-blinded studies using adjuncts to IVRA for surgical procedures was conducted. Data were collected on intraoperative effects (onset/offset and quality of block and tourniquet pain), postoperative effects (pain intensity and analgesic consumption) and side effects recorded. Statistical significance as indicated in the original report and likely clinical relevance were taken into account to arrive at a judgment of overall benefit. PRINCIPAL FINDINGS: Twenty-nine studies met all inclusion criteria. Data on 1,217 study subjects are included. Adjuncts used were opioids (fentanyl, meperidine, morphine, sufentanil), tramadol, non-steroidal anti-inflammatory drugs (NSAIDs; ketorolac, tenoxicam, acetyl-salicylate), clonidine, muscle relaxants (atracurium, pancuronium, mivacurium), alkalinization with sodium bicarbonate, potassium and temperature. There is good evidence to recommend NSAIDs in general and ketorolac in particular, for improving postoperative analgesia. Clonidine 1 microg/kg also appears to improve postoperative analgesia and prolong tourniquet tolerance. Opioids are poor by this route; only meperidine 30 mg or more has substantial postoperative benefit but at the expense of postdeflation nausea, vomiting and dizziness. Muscle relaxants improve intraoperative motor block and aid fracture reduction. CONCLUSION: Using NSAIDs or clonidine as adjuncts to IVRA improves postoperative analgesia and muscle relaxant improves motor block.