Anesthesia and analgesia
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Anesthesia and analgesia · Dec 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA randomized multicenter study of remifentanil compared with halothane in neonates and infants undergoing pyloromyotomy. I. Emergence and recovery profiles.
Pyloric stenosis is sometimes associated with hemodynamic instability and postoperative apnea. In this multicenter study we examined the hemodynamic response and recovery profile of remifentanil and compared it with that of halothane in infants undergoing pyloromyotomy. After atropine, propofol, and succinylcholine administration and tracheal intubation, patients were randomized (2:1 ratio) to receive either remifentanil with nitrous oxide and oxygen or halothane with nitrous oxide and oxygen as the maintenance anesthetic. Pre- and postoperative pneumograms were done and evaluated by an observer blinded to the study. Intraoperative hemodynamic data and postanesthesia care unit (PACU) discharge times, PACU recovery scores, pain medications, and adverse events (vomiting, bradycardia, dysrhythmia, and hypoxemia) were recorded by the study's research nurse. There were no significant differences in patient age or weight between the two groups. There were no significant differences in hemodynamic values between the two groups at the various intraoperative stress points. The extubation times, PACU discharge times, pain medications, and adverse events were similar for both groups. No patient anesthetized with remifentanil who had a normal preoperative pneumogram had an abnormal postoperative pneumogram, whereas three patients with a normal preoperative pneumogram who were anesthetized with halothane had abnormal pneumograms after. ⋯ The use of ultra-short-acting opioids may be an appropriate technique for infants less than 2 mo old when tracheal extubation after surgery is anticipated.
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Anesthesia and analgesia · Dec 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA randomized multicenter study of remifentanil compared with halothane in neonates and infants undergoing pyloromyotomy. II. Perioperative breathing patterns in neonates and infants with pyloric stenosis.
Although former preterm birth infants are at risk for postoperative apnea after surgery, it is unclear whether the same is true of full-term birth infants. We evaluated the incidence of apnea in 60 full-term neonates and infants undergoing pyloromyotomy both before and after anesthesia. All subjects were randomized to a remifentanil- or halothane-based anesthetic. Apnea was defined by the presence of prolonged apnea (>15 s) or frequent brief apnea, as observed on the pneumocardiogram. Apnea occurred before surgery in 27% of subjects and after surgery in 16% of subjects, with no significant difference between subjects randomized to remifentanil or halothane anesthesia. This apnea was primarily central in origin, occurred throughout the recording epochs, and was associated with severe desaturation in some instances. Of the subjects with normal preoperative pneumocardiograms, new onset postoperative apnea occurred in 3 (23%) of 13 subjects who received halothane-based anesthetics versus 0 (0%) of 22 subjects who received remifentanil-based anesthetics (P = 0.04). Thus, postoperative apnea can follow anesthesia in otherwise healthy full-term infants after pyloromyotomy and is occasionally severe with desaturation. New-onset postoperative apnea was not seen with a remifentanil-based anesthetic. ⋯ Abnormal breathing patterns can follow anesthesia in infants after surgical repair of pyloric stenosis. Occasionally, these patterns can be associated with desaturation. New-onset postoperative apnea was not seen with a remifentanil-based anesthetic.
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Anesthesia and analgesia · Dec 2001
Multicenter Study Clinical TrialA dose-determining trial of heparinase-I (Neutralase) for heparin neutralization in coronary artery surgery.
Heparinase-I, a specific heparin-degrading enzyme, may represent an alternative to protamine. We explored the dose of heparinase-I for efficacy and safety in patients undergoing coronary artery surgery. At the conclusion of cardiopulmonary bypass, subjects received 5, 7, or 10 microg/kg of open-label heparinase-I instead of protamine. Activated clotting time (ACT) and its difference from a contemporaneous heparin-free sample (DeltaACT) at 3 min before and 3, 6, and 9 min after heparinase-I determined reversal efficacy. After surgery, we recorded hourly chest tube drainage. Systemic and pulmonary arterial blood pressure and cardiac output measurements before and immediately after heparinase-I were used to evaluate hemodynamic safety. Coagulation measurements included anti-factor Xa and anti-factor IIa activities. Forty-nine patients from seven institutions participated: 12 received 5 microg/kg, 21 received 7 microg/kg, 4 received two doses of 7 microg/kg, 8 received 10 microg/kg, and 4 received two doses of 10 microg/kg. Treatment groups did not differ demographically. Median DeltaACT 9 min later was 11, 7, and 4 s for the 5, 7, and 10 microg/kg groups, respectively. No adverse hemodynamic changes occurred with heparinase-I administration. The authors conclude that heparinase-I effectively restored the ACT after cardiopulmonary bypass. This effect appeared to be dose dependent. ⋯ Heparinase-I (Neutralase(TM)) successfully restored activated coagulation time with no adverse hemodynamic events in patients undergoing coronary artery surgery with cardiopulmonary bypass in an open-label dose-determining trial.
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Anesthesia and analgesia · Nov 2001
Multicenter Study Comparative Study Clinical TrialThe recovery of Senegalese African blacks from intravenous anesthesia with propofol and remifentanil is slower than that of Caucasians.
Differences in sensitivity to anesthetic drugs have already been described among races. This study was designed to comparatively investigate the anesthetic requirements of two different ethnic groups: Caucasians and African blacks. Forty-five Caucasians from Italy and 45 African blacks from Senegal, who underwent general IV anesthesia with propofol and remifentanil, were comparatively evaluated for anesthetic depth and time lapsed before recovery. We used an electroencephalographic-derived index of depth of anesthesia, the bispectral index (BIS), and evaluation of clinical variables to assess the depth of anesthesia and the recovery trend. Mean BIS values from Caucasians after propofol discontinuation returned to baseline (92-100) in approximately 8 min, whereas in African blacks BIS values remained <80 for some 30 min. Time to eye opening was 10.6 +/- 4.8 min in Caucasians versus 16.9 +/- 8.8 min in African blacks (P < 0.001). Time to respond to loud verbal commands was 14.8 +/- 9.1 min in African blacks versus 9.1 +/- 4.2 min in Caucasians (P < 0.01). During anesthetic induction, the mean arterial pressure decreased by 20% in Caucasians and by only 10% in African blacks. We conclude that the recovery from general anesthesia with propofol was slower in African blacks compared with Caucasian patients. ⋯ This study demonstrates statistically significant differences between Caucasians and African blacks in the arousal time from IV anesthesia with propofol and remifentanil. The authors conclude that the recovery from general anesthesia was slower in African blacks compared with Caucasian patients.
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Anesthesia and analgesia · Nov 2001
Randomized Controlled Trial Multicenter Study Clinical TrialThe pharmacokinetics of remifentanil in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.
Remifentanil is a potent opioid with a short duration of action. It has the potential for large-dose opioid anesthesia without an obligatory prolonged period of mechanical ventilation. However, because of high clearance and rapid tissue distribution, cardiopulmonary bypass (CPB) may influence its pharmacokinetics and alter drug requirements. We administered remifentanil by continuous infusion to 68 patients having coronary artery bypass graft surgery during CPB with hypothermia to describe the effects of these interventions on its pharmacokinetics. Remifentanil concentrations were measured before, during, and after CPB. Disposition was best described by a two-compartment model. The volume of distribution increased by 86% with institution of CPB and remained increased after CPB. Elimination clearance decreased by 6.37% for each degree Celsius decrease from 37 degrees C. ⋯ Remifentanil concentrations decrease with the institution of cardiopulmonary bypass because of an increase in the volume of distribution. The decrease in elimination clearance with hypothermia results in increased total remifentanil concentrations during cardiopulmonary bypass if the infusion rate is not altered. More constant blood remifentanil levels may be obtained by reducing remifentanil infusion rate by 30% for each 5 degrees C decrease in temperature.