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 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 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.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Comparative Study Clinical TrialPostoperative sensitization and pain after cesarean delivery and the effects of single im doses of tramadol and diclofenac alone and in combination.
Combining different analgesic mechanisms can reduce postoperative pain. We investigated postoperative pain and sensory sensitization in a double-blinded, placebo-controlled, randomized, single-dose comparison of the monoaminergic and micro -opioid agonist tramadol, 100 mg, and diclofenac 75 mg given IM in combination or alone in 120 patients who had elective cesarean delivery. The time to first postoperative demand for rescue analgesia, pain, tramadol pharmacokinetics, and electrical sensory thresholds at or distant from the incision were studied. The median time to first rescue (interquartile range) was 197 min (70-1000 min) with tramadol plus diclofenac, 48 min (25-90 min) with tramadol plus placebo, 113 min (35-270 min) with diclofenac plus placebo, and 55 min (30-100 min) with double placebo (tramadol plus diclofenac versus all other groups, P < 0.05). Pain intensity decreased markedly over time in all groups, and time and drug effects were significant (analysis of variance; P < 0.00001). Side effects were similarly minimal with all treatments. Pain thresholds at or distant from the incision increased significantly after surgery only with tramadol plus diclofenac. Preoperative sensory thresholds correlated with postoperative sensory changes (r > 0.53; P < 0.0001). The pharmacokinetics of tramadol and O-desmethyltramadol were unchanged by diclofenac. The combination of tramadol and diclofenac resulted in improved analgesia compared with monotherapy. Only the analgesic combination prevented both primary and secondary hyperalgesia. Preoperative sensory thresholds may allow prediction of postoperative sensitization. ⋯ The parenteral combination of tramadol and diclofenac resulted in more prolonged and pronounced postoperative analgesia and reduced sensory sensitization compared with the single drugs, with no increase in side effects.
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Anesthesia and analgesia · Aug 2003
Randomized Controlled Trial Clinical TrialChoice of electrocardiography lead does not affect the usefulness of the T-wave criterion for detecting intravascular injection of an epinephrine test dose in anesthetized children.
Accidental intravascular injection of an epinephrine-containing test dose increases T-wave amplitude of lead II electrocardiogram (EKG) in anesthetized children. We designed this study to test whether the choice of EKG lead would affect the usefulness of simulated intravascular test dose. We studied 32 ASA physical status I infants and children (aged 6-49 mo) undergoing elective surgeries during 1.0 minimum alveolar anesthetic concentration sevoflurane and 67% nitrous oxide in oxygen. When hemodynamic stability was obtained, all subjects received IV saline 0.1 mL/kg, followed 4 min later by an IV test dose (0.1 mL/kg) consisting of 1% lidocaine with 1:200,000 epinephrine (epinephrine 0.5 microg/kg) via a peripheral vein to simulate the intravascular injection of the test dose. Heart rate and systolic blood pressure were recorded every 20 and 60 s, respectively, and leads II (n = 32), V(5) (n = 32) and either lead I (n = 15) or III (n = 17), choosing the one with greater preinjection T-wave amplitude, were continuously recorded for 4 min after the saline and the test dose injections. An IV test dose produced significant increases in heart rate, systolic blood pressure, and T-wave amplitude of all EKG leads studied in all subjects, whereas IV saline elicited no changes in these variables. Maximal increases in T-wave amplitude of leads II, I, III, and V(5) were 158% +/- 69%, 175% +/- 78%, 147% +/- 89%, and 170% +/- 72%, respectively (mean +/- SD, P > 0.05). There was no significant difference in temporal changes in T-wave amplitude among the 4 leads, and sensitivity and specificity were 100% on the basis of the T-wave criterion irrespective of the lead examined. Our results indicate that leads II, I, III, and V(5) of EKG are equally effective for detecting intravascular injection of the epinephrine-containing test dose in sevoflurane-anesthetized children. ⋯ To determine whether an epidurally administered local anesthetic has been accidentally injected into a blood vessel, a small dose of epinephrine is often added to a local anesthetic. We found that increases in T-wave amplitude in leads I, II, III, and V(5) of the electrocardiogram are equally sensitive and specific for detecting intravascular injection of the epinephrine-containing test dose in sevoflurane-anesthetized infants and children.