Anesthesia and analgesia
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Multicenter Study Clinical TrialDiaspirin-crosslinked hemoglobin reduces blood transfusion in noncardiac surgery: a multicenter, randomized, controlled, double-blinded trial.
In this randomized, prospective, double-blinded clinical trial, we sought to investigate whether diaspirin-crosslinked hemoglobin (DCLHb) can reduce the perioperative use of allogeneic blood transfusion. One-hundred-eighty-one elective surgical patients were enrolled at 19 clinical sites from 1996 to 1998. Selection criteria included anticipated transfusion of 2-4 blood units, aortic repair, and major joint or abdomino-pelvic surgery. Once a decision to transfuse had been made, patients received initially up to 3 250-mL infusions of 10% DCLHb (n = 92) or 3 U of packed red blood cells (PRBCs) (n = 89). DCLHb was infused during a 36-h perioperative window. On the day of surgery, 58 of 92 (64%; confidence interval [CI], 54%-74%) DCLHb-treated patients received no allogeneic PRBC transfusions. On Day 1, this number was 44 of 92 (48%; CI, 37%-58%) and decreased further until Day 7, when it was 21 of 92 (23%; CI, 15%-33%). During the 7-day period, 2 (1-4) units of PRBC per patient were used in the DCLHb group compared with 3 (2-4) units in the control patients (P = 0.002; medians and 25th and 75th percentiles). Mortality (4% and 3%, respectively) and incidence of suffering at least one serious adverse event (21% and 15%, respectively) were similar in DCLHb and PRBC groups. The incidence of jaundice, urinary side effects, and pancreatitis were more frequent in DCLHb patients. The study was terminated early because of safety concerns. Whereas the side-effect profile of modified hemoglobin solutions needs to be improved, our data show that hemoglobin solutions can be effective at reducing exposure to allogeneic blood for elective surgery. ⋯ In a randomized, double-blinded red blood cell controlled, multicenter trial, diaspirin-crosslinked hemoglobin spared allogeneic transfusion in 23% of patients undergoing elective noncardiac surgery. The observed side-effect profile indicates a need for improvement in hemoglobin development.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Comparative Study Clinical TrialIsobaric versus hypobaric spinal bupivacaine for total hip arthroplasty in the lateral position.
Total hip arthroplasty (THA) is frequently performed under spinal anesthesia using either isobaric or hypobaric anesthetic solution. However, these two solutions have never been compared under similar surgical conditions. In the present study, we compared the anesthetic and hemodynamic effects of isobaric and hypobaric bupivacaine in 40 ASA physical status I-II patients undergoing THA in the lateral decubitus position under spinal anesthesia. With operative side up, patients randomly received, in a double-blinded manner, a spinal injection of 3.5 mL (17.5 mg) of plain bupivacaine mixed with either 1.5 mL of normal saline (isobaric group) or 1.5 mL of distilled water (hypobaric group). Sensory level and degree of motor block were evaluated on the nondependent and dependent sides until regression to L2 and total motor recovery. Hemodynamic changes during the first 45 min after spinal injection, and the time between spinal administration and first analgesic for a pain score >3 (on a 0-10 scale) were noted. Demographic characteristics of both groups were comparable. Upper sensory level and maximal degree of motor block were comparable between the operative and nonoperative sides in each group and between corresponding sides in both groups. Compared with the isobaric group, in the hypobaric group there was a prolonged time to sensory regression to L2 on the operative side (287 +/- 51 versus 242 +/- 36 min, P < 0.004) and a prolonged time to first analgesic (290 +/- 46 versus 237 +/- 39 min, P < 0.001). No difference in quality of motor block was noted at the end of surgery. Hemodynamic changes were comparable. We conclude that for THA in the lateral position, spinal hypobaric bupivacaine seems to be superior to isobaric in that it prolongs the sensory block on the operative side and delays the use of analgesics after surgery without further compromising hemodynamic stability. ⋯ For total hip arthroplasty in the lateral position, spinal hypobaric bupivacaine compared with isobaric prolonged sensory block at the operative side and delayed the time to first analgesic.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Comparative Study Clinical TrialA comparison of three different concentrations of levobupivacaine for caudal block in children.
We investigated three different concentrations of levobupivacaine (0.125%, 0.20%, and 0.25%; n = 20 in each group) for caudal blockade in a prospective, randomized, observer-blinded fashion in children (1-7 yr) undergoing subumbilical surgery. The duration of postoperative analgesia was assessed as the time to first administration of supplemental analgesia (based on a Childrens and Infants Postoperative Pain Scale score of >or=4), and the degree of immediate postoperative motor blockade was determined by use of a 3-point scale. A dose-response relationship was observed both with regard to median duration of postoperative analgesia (0.125%, 60 min; 0.20%, 118 min; 0.25%, 158 min) and the number of patients with evidence of early postoperative motor blockade (0.125%, 0; 0.20%, 4; 0.25%, 8). The 0.125% concentration was associated with significantly less early motor blockade (P = 0.003) but was found to result in a significantly shorter duration of postoperative analgesia (P < 0.05). Based on these results, the use of 0.20% levobupivacaine might represent the best clinical option if a plain levobupivacaine solution is to be used for caudal blockade in children. ⋯ The use of 0.125% levobupivacaine for caudal blockade (1 mL/kg) in children (1-7 yr) was associated with less early postoperative motor blockade but a shorter duration of postoperative analgesia compared with 0.20% and 0.25% solutions.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Clinical TrialThe central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers.
We compared the central nervous system (CNS) and cardiovascular effects of levobupivacaine and ropivacaine when given IV to healthy male volunteers (n = 14) in a double-blinded, randomized, crossover trial. Subjects received levobupivacaine 0.5% or ropivacaine 0.5% after a test infusion with lidocaine to become familiar with the early signs of CNS effects (e.g., tinnitus, circumoral paresthesia, hypesthesia). The development of CNS symptoms was assessed at 1-min intervals and study drug administration was terminated when the first CNS symptoms were recognized. Thereafter, symptoms were recorded at 1-min intervals until symptom resolution. Hemodynamic variables were assessed by transthoracic electrical bioimpedance. Continuous 12-lead electrocardiogram monitoring was also performed. There was no significant difference between levobupivacaine and ropivacaine for: the mean time to the first onset of CNS symptoms (P = 0.870), mean total volume of study drug administered at the onset of the first CNS symptom (P = 0.595), stroke index (P = 0.678), cardiac index (P = 0.488), acceleration index (P = 0.697), PR interval (P = 0.213), QRS duration (P = 0.637), QT interval (P = 0.724), QTc interval (P = 0.737), and heart rate (P = 0.267). Overall, fewer CNS symptoms were reported for levobupivacaine than ropivacaine (218 versus 277). This study found that levobupivacaine and ropivacaine produce similar CNS and cardiovascular effects when infused IV at equal concentrations, milligram doses, and infusion rates. ⋯ This study compared directly, for the first time, the toxicity of levobupivacaine and ropivacaine in healthy volunteers. Levobupivacaine and ropivacaine produced similar central nervous system and cardiovascular effects when infused IV at equal concentrations, milligram doses, and infusion rates.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Clinical TrialThe effect of exogenous epinephrine on the incidence of hypotensive/bradycardic events during shoulder surgery in the sitting position during interscalene block.
Sudden hypotensive and/or bradycardic events (HBE) have been reported in 13%-28% of patients undergoing shoulder surgery in the sitting position during interscalene block. The Bezold-Jarisch reflex is the most likely mechanism for these events. It has been hypothesized that exogenous epinephrine might be a key component to the occurrence of HBE. We conducted this prospective, randomized study to verify this hypothesis. Patients received a local anesthetic solution with (Group E; n = 55) or without (Group P; n = 55) epinephrine for interscalene block; no further exogenous epinephrine was administered. Blood pressure control was achieved with IV urapidil, a peripheral vasodilator, as needed. The incidence of HBE was 11% in Group P versus 29% in Group E (P = 0.015). Increased intraoperative heart rate and arterial blood pressure were recorded in Group E (P = 0.000). Urapidil was administered to 13% of Group P and to 31% of Group E patients (P = 0.018). Urapidil administration induced a HBE in 4% of Group P and in 5% of Group E patients. We conclude that exogenous epinephrine is involved in the development of HBE in this setting. ⋯ Sudden hypotensive and/or bradycardic events occur during shoulder surgery in the sitting position during interscalene block. In this study, we demonstrated that the presence of epinephrine in the local anesthetic mixture significantly increases the incidence of these events.