Double-blinded Study (double-blinded + study)

Distribution by Scientific Domains


Selected Abstracts


Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy

ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2010
I. M. SAADAWY
Background: This double-blinded study aimed at evaluating and comparing the effects of magnesium and lidocaine on pain, analgesic requirements, bowel function, and quality of sleep in patients undergoing a laparoscopic cholecystectomy (LC). Methods: Patients were randomized into three groups (n=40 each). Group M received magnesium sulfate 50 mg/kg intravenously (i.v.), followed by 25 mg/kg/h i.v., group L received lidocaine 2 mg/kg i.v., followed by 2 mg/kg/h i.v., and group P received saline i.v. Bolus doses were given over 15 min before induction of anesthesia, followed by an i.v. infusion through the end of surgery. Intraoperative fentanyl consumption and averaged end-tidal sevoflurane concentration were recorded. Abdominal and shoulder pain were evaluated up to 24 h using a visual analog scale (VAS). Morphine consumption was recorded at 2 and 24 h, together with quality of sleep and time of first flatus. Results: Lidocaine or magnesium reduced anesthetic requirements (P<0.01), pain scores (P<0.05), and morphine consumption (P<0.001) relative to the control group. Lidocaine resulted in lower morphine consumption at 2 h [4.9 ± 2.3 vs. 6.8 ± 2.8 (P<0.05)] and lower abdominal VAS scores compared with magnesium (1.8 ± 0.8 vs. 3.2 ± 0.9, 2.2 ± 1 vs. 3.6 ± 1.6, and 2.1 ± 1.4 vs. 3.3 ± 1.9) at 2, 6, and 12 h, respectively (P<0.05). Lidocaine was associated with earlier return of bowel function and magnesium was associated with better sleep quality (P<0.05). Conclusion: I.v. lidocaine and magnesium improved post-operative analgesia and reduced intraoperative and post-operative opioid requirements in patients undergoing LC. The improvement of quality of recovery might facilitate rapid hospital discharge. [source]


Bone Material Properties in Trabecular Bone From Human Iliac Crest Biopsies After 3- and 5-Year Treatment With Risedronate,,

JOURNAL OF BONE AND MINERAL RESEARCH, Issue 10 2006
Erich Durchschlag
Abstract Long-term effects of risedronate on bone mineral maturity/crystallinity and collagen cross-link ratio in triple iliac crest biopsies of osteoporotic women were evaluated. In this double-blinded study, 3- and 5-year treatment with risedronate arrested the tissue aging encountered in untreated osteoporosis and in osteoporosis treated with other antiresorptives. This effect may be contributing to risedronate's antifracture efficacy. Introduction: Risedronate is widely used in the treatment of osteoporosis. It reduces bone turnover, increases BMD, and decreases fracture risk. To date, there are no data available on the long-term effects of risedronate on bone material properties in humans. Materials and Methods: Osteoporotic women enrolled in the VERT-NA trial received either risedronate (5 mg/day, orally) or placebo for up to 5 years. All subjects received calcium. They also received vitamin D supplementation if deficient at baseline. Triple iliac crest biopsies were collected from a subset of these subjects at baseline, 3 years, and 5 years. Mineral maturity/crystallinity and collagen cross-link ratio was measured in these biopsies using Fourier transform infrared imaging. Results: Patients that received placebo exhibited increased mineral maturity/crystallinity and collagen cross-link ratio after 3 and 5 years compared with baseline values. On the contrary, patients that received risedronate retained baseline values in both bone material indices throughout. A more spatially detailed analysis revealed that this was achieved mainly through beneficial effects on active bone-forming areas. Surprisingly, patients that received risedronate achieved premenopausal values at bone-forming areas in both indices after 5 years of treatment. Conclusion: Long-term treatment with risedronate affects bone material properties (mineral maturity/crystallinity and collagen cross-link ratio) and arrests the tissue aging apparent in untreated osteoporosis. These changes at the material level of the bone matrix may contribute to risedronate's rapid and sustained antifracture efficacy in osteoporotic patients. [source]


Serum TRACP 5b Is a Useful Marker for Monitoring Alendronate Treatment: Comparison With Other Markers of Bone Turnover,

JOURNAL OF BONE AND MINERAL RESEARCH, Issue 10 2005
Arja Nenonen MSc
Abstract We studied clinical performance of serum TRACP 5b and other bone turnover markers, including S-CTX, U-DPD, S-PINP, S-BALP, and S-OC, for monitoring alendronate treatment. TRACP 5b had higher clinical sensitivity, area under the ROC curve, and signal-to-noise ratio than the other markers. Introduction: The purpose of this study was to compare the clinical performance of serum TRACP 5b (S-TRACP5b) with that of other markers of bone turnover in the monitoring of alendronate treatment. Materials and Methods: This double-blinded study included 148 healthy postmenopausal women that were randomly assigned into two groups: one receiving 5 mg alendronate daily (n = 75) and the other receiving placebo (n = 73) for 12 months. All individuals in both groups received calcium and vitamin D daily. The bone resorption markers S-TRACP5b, serum C-terminal cross-linked telopeptides of type I collagen (S-CTX), and total urinary deoxypyridinoline (U-DPD), and the serum markers of bone formation procollagen I N-terminal propeptide (S-PINP), bone-specific alkaline phosphatase (S-BALP), and total osteocalcin (S-OC) were assessed at baseline and at 3, 6, and 12 months after initiation of treatment. Lumbar spine BMD (LBMD) was measured at baseline and 12 months. Results: Compared with the placebo group, LBMD increased, and all bone markers decreased significantly more in the alendronate group (p < 0.001 for each parameter). The decrease of S-TRACP5b after first 3 months of alendronate treatment correlated significantly with the changes of all other markers except S-OC, the best correlation being with S-CTX (r = 0.60, p < 0.0001). The changes of LBMD at 12 months only correlated significantly with the changes of S-TRACP5b (r = ,0.32, p = 0.005) and S-CTX (r = ,0.24, p = 0.037) at 3 months. Based on clinical sensitivity, receiver operating characteristic (ROC) curves, and signal-to-noise ratio, S-TRACP5b, S-CTX, and S-PINP were the best markers for monitoring alendronate treatment. Clinical sensitivity, area under the ROC curve, and signal-to-noise ratio were higher for S-TRACP5b than for the other markers. Conclusion: These results show that S-TRACP5b, S-CTX, and S-PINP are useful markers for monitoring alendronate treatment. [source]


Hyper osmolality does not modulate natriuretic peptide concentration in patients after coronary artery surgery

ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2009
E. L. HONKONEN
Background: The heart secretes natriuretic peptides (NPs) in response to myocardial stretch. Measuring NP concentrations is a helpful tool in guiding treatment. It has been suggested that sodium ion and hyperosmolality could affect NP excretion. If this is true, peri-operative NP measurements could be inconsistent when hypertonic solutions are used. With different osmolalities but equal volumes of hydroxyethyl starch (HES) , and hypertonic saline (HS) , infusions, this double-blinded study tested the hypothesis that osmolality modulates the excretion of NPs. Methods: Fifty coronary surgery patients were randomized to receive within 30 min 4 ml/kg either HS or HES post-operatively. Samples for analysis of atrial NP (ANP), brain NP (BNP), plasma and urine sodium and osmolality and urine oxygen tension were obtained before and 60 min after starting the infusions and on the first post-operative morning. The haemodynamic parameters were measured at the same time points. Results: Plasma osmolality and sodium increased only in the HS group. Changes in plasma BNP and ANP levels did not differ between the groups (P=0.212 and 0.356). There were no correlations between NP levels and osmolality or sodium at any time point. In the HS group, urine volume was higher (3295 vs. 2644 ml; P<0.05) and the need for furosemide treatment was less (0.4 vs. 3.8 mg; P<0.01) than in the HES group. Conclusions: The absence of effects of plasma sodium content or hyperosmolality on NP release validates the value of NPs as a biomarker in peri-operative patients. [source]


Subhypnotic propofol infusion plus dexamethasone is more effective than dexamethasone alone for the prevention of vomiting in children after tonsillectomy

PEDIATRIC ANESTHESIA, Issue 9 2008
ALI FUAT ERDEM MD
Summary Background:, Postoperative vomiting (POV) is a common complication after tonsillectomy. Dexamethasone is known to decrease postsurgical vomiting. In this study, we compared the effects of dexamethasone alone to dexamethasone plus propofol on postoperative vomiting in children undergoing tonsillectomy. Methods:, In a randomized double-blinded study, we evaluated 80 healthy children, aged 4,12 years, who underwent tonsillectomy with or without adenoidectomy. After anesthesia was induced by inhalation of sevoflurane, 0.15 mg·kg,1 dexamethasone and 2 ,g·kg,1 fentanyl was administered i.v. to all patients. The patients in the dexamethasone plus propofol group received 1 mg·kg,1 propofol before intubation and continuously after intubation at a rate of 20 ,g·kg,1·min,1 until the surgery was completed. Data for postoperative vomiting were grouped into the following time periods: 0,4 and 4,24 h. Data were analyzed using a Student's t -test and chi-squared analysis. Results:, The percentage of patients exhibiting a complete response (defined as no retching or vomiting for 24 h) increased from 37.5% in the dexamethasone-alone group to 75% in the dexamethasone plus propofol group (P = 0.001). Twenty-two patients (55%) in the dexamethasone-alone and nine patients (22.5%) in the dexamethasone plus propofol groups experienced vomited during 0,4 h (P = 0.003). Eight patients in the dexamethasone-alone group and three patients in the dexamethasone plus propofol group received ondansetron as a rescue antiemetic during the postoperative period. Conclusion:, For children undergoing tonsillectomy, intraoperative subhypnotic propofol infusion combined with dexamethasone treatment provides a better prophylaxis against postoperative vomiting than does dexamethasone alone. [source]


Effect of oral midazolam premedication on the awakening concentration of sevoflurane, recovery times and bispectral index in children

PEDIATRIC ANESTHESIA, Issue 5 2001
Keith K. Brosius MD
Background: We sought to determine the influence of preoperative oral midazolam on: (i) measures of anaesthetic emergence; (ii) recovery times and (iii) intraoperative bispectral index (BIS) measurements during sevoflurane/N2O anaesthesia in paediatric patients. Methods: Fifty-two patients, aged 1,10 years, ASA I,II, were enrolled in a prospective double-blinded study. Patients were randomized to receive either midazolam 0.5 mg·kg,1 (M) or midazolam vehicle (P) as premedication. After inhalation induction and intubation, expired sevoflurane was stabilized at 3% in 60% N2O and the corresponding BIS (BIS I) recorded. At the completion of surgery, sevoflurane was stabilized at 0.5% and the BIS (BIS E) again recorded. Awakening time, expired sevoflurane/N2O awakening concentrations and recovery times were recorded. Results: There were no significant differences between groups in awakening time, sevoflurane or N2O awakening concentrations, time to PACU discharge, time to hospital discharge or in BIS I and BIS E measurements. [source]