Articles: anesthesia.
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Anesthesia and analgesia · Oct 1993
Multicenter Study Clinical TrialHemodynamic effects of propofol: data from over 25,000 patients.
To investigate clinically important hypotension and bradycardia after induction of anesthesia with propofol, we analyzed data from a Phase IV stepwise study involving 25,981 patients, 1722 institutions, and 1819 anesthesiologists. In Step 1, propofol was used for induction only. In Step 2, propofol was used for induction and then maintenance by intermittent injection. ⋯ Giving this new drug by protocol, even inexperienced anesthesiologists incurred few adverse hemodynamic changes. Hemodynamic changes were transient and rarely (< 0.2%) required drug therapy. Cardiovascular changes and drug interactions were predictable and manageable based on knowledge of the pharmacology of propofol.
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Anesthesia and analgesia · Oct 1993
Multicenter Study Clinical TrialAdverse events in a multicenter phase IV study of propofol: evaluation by anesthesiologists and postanesthesia care unit nurses.
Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug. However, because postapproval Phase IV studies involve a much larger and more complex population, the true nature of adverse effects can be seen. We analyzed Phase IV data for the new drug propofol with regard to the incidence of adverse events, and evaluations of such events by anesthesiologists versus postanesthesia care unit (PACU) nurses. ⋯ The PACU nurse was more influenced by nausea, vomiting, or postoperative pain; and the anesthesiologist was more influenced by postoperative confusion or delayed emergence from anesthesia. For only 0.6% of patients did both evaluators rate recovery as poor. Anesthesiologists gave more weight to intraoperative adverse events, and nurses to postoperative events.(ABSTRACT TRUNCATED AT 250 WORDS)
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Anesthesia and analgesia · Oct 1993
Multicenter Study Clinical TrialEffects on recovery when isoflurane is used to supplement propofol-nitrous oxide anesthesia.
During propofol-nitrous oxide (N2O) anesthesia, volatile anesthetics are frequently administered to treat signs of inadequate anesthesia and to decrease the possibility of intraoperative awareness. Because the clinical effects of this combination have not been examined rigorously, we used data from the 1989-90 Phase IV clinical trial with propofol to evaluate recovery from propofol-N2O anesthesia with and without supplementation with isoflurane. In this study involving 15,806 patients at 1722 institutions, propofol was administered for induction and maintenance of anesthesia with N2O for procedures lasting less than 60 min. ⋯ Adjunctive use of isoflurane prolonged the time to awakening and to becoming oriented, but discharge times were similar for the two groups. The incidence of postoperative nausea, vomiting, recall, and excitement did not differ between the two groups. We conclude that the addition of isoflurane to a propofol-N2O anesthetic does not alter recovery from anesthesia.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Perioperative morbidity in patients randomized to epidural or general anesthesia for lower extremity vascular surgery. Perioperative Ischemia Randomized Anesthesia Trial Study Group.
Perioperative morbidity may be modifiable in high risk patients by the anesthesiologist's choice of either regional or general anesthesia. This clinical trial compared outcomes between epidural (EA) and general (GA) anesthesia/analgesia regimens in a group of patients at high risk for cardiac and other morbidity who were undergoing similarly stressful surgical procedures. ⋯ Carefully conducted epidural and general anesthesia appear to be associated with comparable rates of cardiac and most other morbidity in patients undergoing lower extremity vascular surgery. However, compared with general anesthesia, epidural anesthesia is associated with a lower incidence of reoperation for inadequate tissue perfusion and, therefore, may be advantageous for this surgical population.
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Regional anesthesia · Jul 1993
Multicenter Study Clinical TrialAtraucan: a new needle for spinal anesthesia.
Atraucan 26-gauge spinal needles have a tip designed to make a small linear cut (as opposed to a V-shaped cut) in the dura mater. The cut is shorter than the outside diameter of the needle and is dilated as the needle passes through the dura. The needle is used with a 20-gauge introducer. In vitro, it causes less leakage of cerebrospinal fluid than Quincke 26-gauge or Sprotte 24-gauge needles. This study was designed to test the ease of use and any damage caused to the needle tip during lumbar dural puncture. ⋯ The Atraucan needle is easy to use and has a high success rate in identifying the subarachnoid space. Lumbar dural puncture causes minimal damage to the tip. The incidence of PDPH is low, but a larger comparative study needs to be performed.