Anesthesia and analgesia
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Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Clinical TrialAssessment of the safety and tolerance of 6% hydroxyethyl starch (200/0.5) solution: a randomized, controlled epidemiology study.
None of the natural and synthetic colloids currently available is free from the risk of side effects. This study was performed to contribute to the epidemiology of adverse reactions of the widely used 200/0.5 hydroxyethyl starch 6% solution (HES). Study end points were anaphylactoid reactions during preanesthesia infusion and perioperative course, and pruritus 5 days postoperatively (clinical examination and inquiry) and 8 wk after application (mailed patient questionnaire). We consecutively randomized 750 patients undergoing minor elective surgery into two parallel groups treated with HES (from two different manufacturers) and one control group treated with lactated Ringer's solution. The study population was well matched among the groups and consisted of patients of both sexes, aged 18-95 yr, ASA physical status I-III. No drug-related anaphylactoid reactions were detected during either of the observation intervals. There was no episode of pruritus after the fifth postoperative day. Incidence of pruritus after 8 wk was quite frequent but not significantly different (chi2 test, P = 0.77): 9.1% and 12.0% in the two HES groups and 11.5% in the lactated Ringer's solution control group. Except for pruritus, we conclude that HES was associated with no more complications than lactated Ringer's solution. ⋯ Anaphylactoid reactions and pruritus (itching) after the administration of a 6% hydroxyethyl starch (200/0.5) versus lactated Ringer's solution were assessed in a prospective, randomized, controlled study. There were no differences, although there was a more than 10% incidence of pruritus in both groups.
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Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Comparative Study Clinical TrialThe pharmacokinetics of acetyl starch as a plasma volume expander in patients undergoing elective surgery.
Acetyl starch (ACS) is a new synthetic colloid solution for plasma volume expansion and is now undergoing phase 2 clinical trials. We compared the pharmacokinetics of ACS with those of hydroxyethyl starch (HES) in 32 patients (ASA physical status I and II) undergoing elective surgery. In this randomized, double-blind trial, patients received either 15 mL/kg ACS 6% (average molecular weight [Mw] 200,000/molar substitution [MS] 0.5) or HES 6% (Mw 200,000/MS 0.5) i.v. up to a maximal dose of 1000 mL. Plasma colloid concentrations were measured by repetitive arterial blood sampling over 24.5 h. Plasma colloid concentrations were detected using a high-pressure liquid chromatography controlled enzymatic test. Standard pharmacokinetics were calculated, including initial half-life (t(1/2init)), i.e., the time required for a 50% decline of the maximal plasma colloid concentration at the end of drug infusion. Whereas HES was eliminated by second-order kinetics, ACS followed first-order characteristics. In the first hours after i.v. administration, t(1/2init) and clearances were similar in both groups. However, the terminal half-life of HES was significantly longer than that of ACS (9.29 +/- 1.43 h vs 4.37 +/- 1.06 h). After 16.5 and 24.5 h, ACS showed significantly lower plasma concentrations than HES, which indicates that the final degradation of ACS by esterases and amylase was significantly more rapid. ACS might be an alternative plasma volume expander, which avoids the accumulation of persisting macromolecules. ⋯ We studied the pharmacokinetics of acetyl starch, a newly developed colloid solution for plasma volume substitution, compared with hydroxyethyl starch in 32 surgical patients undergoing elective major general surgical procedures. In contrast to hydroxyethyl starch, this new agent undergoes rapid and nearly complete enzymatic degradation.
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Anesthesia and analgesia · Apr 1998
Randomized Controlled Trial Comparative Study Clinical TrialIs there a better right-sided tube for one-lung ventilation? A comparison of the right-sided double-lumen tube with the single-lumen tube with right-sided enclosed bronchial blocker.
Anatomic variation between tracheal carina and the take-off of the right upper bronchus often makes the use of a right-sided double-lumen tube (R-DLT) or a single-lumen tube with right-sided enclosed bronchial blocker tube (R-UBB) (Univent) undesirable. This study compared the R-DLT with the R-UBB to determine whether there was any advantage of one over the other during anesthesia with one-lung ventilation (OLV) for right-sided thoracic surgeries. Forty patients requiring right lung deflation were randomly assigned to one of two groups. Twenty patients received a right-sided BronchoCath double-lumen tube, and 20 received a Univent tube with a bronchial blocker placed in the right mainstem bronchus. The following were studied: 1) time required to position each tube until satisfactory placement was achieved; 2) number of times that fiberoptic bronchoscopy was required (including one with the patient supine and one in lateral decubitus position); 3) number of malpositions after initial confirmation of tube placement; 4) time required until lung collapse; 5) surgical exposure; and 6) cost of tubes per case. No differences were found with any of these variables except that the cost of acquisition overall was greater for the R-UBB than for the R-DLT. No right upper lobe collapse was observed in the postoperative period in the chest radiograph in any of the patients studied. We conclude that either tube can be used safely and effectively for right-sided thoracic surgeries that require anesthesia for OLV. ⋯ In this study, right-sided double-lumen tubes were compared with the Univent with right-sided bronchial blockers. The results indicate that either tube can be used for right-sided thoracic surgery.