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Wound sepsis following gastrointestinal surgery: a comparison of topical and two-dose systemic cephradine.

A prospective study of the effect of the route of administration of prophylactic antibiotic on the wound infection rate following gastrointestinal surgery was performed. Patients were randomly allocated to one of three groups: group 1 received no form of antibiotic prophylaxis; group 2 received 1 g of cephradine applied topically to the wound at closure; group 3 received 1 g of cephradine intravenously at induction of anaesthesia and a further intravenous dose of 500 mg 4 h later. Wound infections occurred in 12 of 83 patients in the control group (14.5 per cent), in 6 of the 83 patients in the group who received topical antibiotic (7.2 per cent) and in 3 of the 82 patients who received systemic antibiotics (3.6 per cent). Only the group who received systemic antibiotic showed a statistically significant reduction in the incidence of wound infections compared with the control group (P = 0.03).

Administration, Topical↗

[Treatment of severe febrile neutropenia (author's transl)].

Random allocation of 22 patients with benign and malignant diseases with neutrophil counts of up to 1 X 10(9)/l blood and probably infection-caused fever of more than 38 degrees C to intravenous treatment with one of the following antibiotic combinations was performed: carbenicillin (6 g/m(2) . 6 h) plus sisomicin (45 g/m2 . 6 h) or mezlocillin (3 g/m2 . 6 h) plus sisomicin (45 g/m2 . 6 h). Both combinations were tolerated equally well. Patients became afebrile in 16 out of 23 treatment periods. Seven out of 11 patients responded to carbenicillin - sisomicin, and 9 out of 12 to mezlocillin - sisomicin. Mezlocillin thus leads to equal success of treatment in febrile neutropenia as the double dose of carbenicillin when both antibiotics are combined with the same aminoglycoside.

Agranulocytosis↗

Comparison of sublingual lorazepam with intramuscular diazepam as sedatives during oral surgery.

Sublingual lorazepam (2 to 3 mg) was compared with intramuscular diazepam (0.25 mg/kg) and placebo for sedation during oral surgery under local anesthesia. Sixty patients were randomly allocated into three groups in this double-blind, parallel study. The results from this trial show that sublingually administered lorazepam provided good sedation and anxiolysis. More side-effects, such as giddiness, dizziness, and ptosis, as well as profound and prolonged psychomotor impairment, were, however, found in the lorazepam group than in those patients who had received intramuscular diazepam (0.25 mg/kg) or placebo.

Administration, Sublingual↗

A randomised prospective comparison of cefotaxime versus netilmicin/penicillin for treatment of suspected neonatal sepsis.

In an open prospective study performed in 2 neonatal units, infants with suspected neonatal sepsis (SNS) of unknown microbial cause were randomly allocated to receive treatment with either cefotaxime (CTX) or netilmicin plus penicillin (N + P). 236 patients were entered into the trial, of whom 222 were evaluable. The number of 'definitely' and 'probably' infected babies was similar in both groups. There was no difference in clinical outcome between patients in the 2 treatment groups and no side effects were recorded for either of the antibiotic regimens. Antibiotic sensitivity testing of bacterial isolates from peripheral sites showed almost universal sensitivity of potential pathogens to both antibiotic regimens at the start of treatment in all infants. Thereafter, organisms resistant to CTX were isolated from patients in both treatment groups, possibly reflecting the antibiotic sensitivity profile of the colonising bacteria in both neonatal units. The results of this study indicate that either CTX or N + P are suitable, in our units, for the 'blind' treatment of early SNS. In units where listerial infections are prevalent, specific cover should be added to CTX. For SNS developing after admission, the choice of antibiotics will depend upon the background antibiotic sensitivity profile of the colonising bacteria.

Bacterial Infections↗

Comparison of bupivacaine and alkalinized bupivacaine in brachial plexus anesthesia.

To define the effect of alkalinization of bupivacaine 0.5% in subclavian perivascular brachial plexus blockade, the time to onset, time to peak effect, and 6-hour regression of sensory and motor blockade were determined. Sixty physical status ASA I and II patients were randomly allocated to one of two groups and a double-blind design was used: group I (n = 30) received bupivacaine 0.5% (pH, 5.5) 3 mg/kg, while group II (n = 30) received alkalinized bupivacaine 0.5% (pH, 7.05-7.15) 3 mg/kg. Onset and regression of sensory blockade were determined by pinprick in the C4-T2 skin dermatomes, while motor blockade was assessed using a scheme of proximal to distal muscle group paralysis. Time to onset of sensory blockade (group I, 4.0 +/- 1.2 min; group II, 3.6 +/- 0.9 min) and time to peak sensory effect (group I, 17.7 +/- 1.8 min; group II, 16.3 +/- 1.8 min) did not differ significantly between the groups. Similarly, no difference in time to onset of motor blockade (group I, 6.9 +/- 1.7 min; group II, 6.3 +/- 1.5 min) or time to peak motor effect (group I, 18.1 +/- 1.9 min; group II, 15.1 +/- 1.9 min) was observed. Regression of postoperative sensory and motor blockade was similar in both groups. It is concluded that alkalinization of bupivacaine 0.5% solutions does not confer any added clinical advantage in subclavian perivascular brachial plexus blockade when compared with commercially available bupivacaine.

Adolescent↗

Combination of passive and active immunization in honeybee venom immunotherapy.

Immunotherapy with honeybee venom (HBV) is effective under optimal conditions, but many untoward systemic reactions are observed when venom doses are increased, especially with rush protocols. Although there were large interpatient variations, the levels of serum been venom specific IgG were found to significantly correlate with the protection of the allergic patients. A double-blind, placebo-controlled study was carried out to determine whether passive immunization with fractionated IgG from a beekeeper's serum pool was able to protect patients undergoing a rush immunotherapy program with HBV against untoward systemic reactions, and to observe if the active immunization with HBV could elicit an active IgG immune response toward venom allergens. Hyperimmune IgG was obtained from a pool of sera of beekeepers (Cohn fractions II to III) that was subsequently treated with pepsin for intravenous use. All IgG subclasses were found to be present in the preparation. Twenty-seven patients, highly allergic to HBV, were randomly allocated to two treatment groups. Twenty patients received 10 to 15 gm of fractionated IgG, and seven other patients received saline in a double-blind fashion. The next day, a 3-hour rush protocol attempted to reach a cumulative venom dose of 200 micrograms; 16/20 patients who received the fractionated IgG reached this dose without any systemic reaction, whereas none of the seven subjects who received saline could attain it, and all patients had a systemic reaction. The active immunization with HBV elicited a significant (p less than 0.05; Wilcoxon W Test) increase in venom IgG after 1 week of treatment in the patients who reached the maintenance dose.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Alfentanil-supplemented anaesthesia for short procedures. A double-blind comparison with fentanyl.

Eighty unpremedicated female patients undergoing short gynaecological procedures were randomly allocated to four groups and received either alfentanil or fentanyl (double-blind), together with Althesin-oxygen or methohexitone-nitrous oxide'-oxygen. Recovery from anaesthesia was assessed using the post-box test and the deletion of p. There was a significantly greater frequency of vomiting after operation (P less than 0.05) with methohexitone compared with Althesin and with fentanyl compared with alfentanil, and a significantly greater frequency of pain on injection (P less than 0.001) with methohexitone compared with Althesin. The alfentanil groups completed the post-box test significantly earlier after operation than the fentanyl groups (P less than 0.05). We conclude that alfentanil may offer a significant advantage over fentanyl as an analgesic supplement to i.v. anaesthesia for short procedures.

Adjuvants, Anesthesia↗

Prospective randomized trial of intravenous and intracoronary streptokinase in acute myocardial infarction.

To evaluate the relative thrombolytic efficacy and complications of intracoronary vs high-dose, short-term intravenous streptokinase infusion in patients with acute myocardial infarction, we performed baseline coronary arteriography and then randomly allocated 51 patients with acute myocardial infarction to receive either intracoronary (n = 25) or intravenous (n = 26) streptokinase. Patients getting the drug by the intracoronary route received 240,000 IU of streptokinase into the infarct-related artery over 1 hr, whereas those getting the drug by the intravenous route received either 500,000 IU of streptokinase over 15 min (n = 10) or 1 million IU of streptokinase over 45 min (n = 16). Angiographically observed thrombolysis occurred in 76% (19/25) of the patients receiving intracoronary streptokinase, in 10% (1/10) of the patients receiving 500,000 IU of streptokinase intravenously, and in 44% (7/16) of the patients receiving 1 million IU of streptokinase intravenously. Among patients in whom thrombolysis was observed, mean elapsed time from onset of streptokinase infusion until lysis was 31 +/- 18 min in patients receiving intracoronary streptokinase and 38 +/- 20 min in those receiving intravenous streptokinase (p = NS). Among patients in whom intravenous streptokinase "failed," intracoronary streptokinase in combination with intracoronary guidewire manipulation recanalized only 7% (1/15). Fibrinogen levels within 6 hr after streptokinase were significantly lower in the patients receiving intravenous streptokinase (39 +/- 17 mg/dl) than the levels in those receiving intracoronary streptokinase (88 +/- 70 mg/dl) (p less than .05) but were similar 24 hr after streptokinase in the two groups. Bleeding requiring transfusion occurred in one patient in each group. Thus, in this prospective randomized trial of intracoronary vs intravenous streptokinase, hemorrhagic complications were few, although both regimens produced a systemic lytic state. Although the thrombolytic efficacy of intracoronary streptokinase was superior to that of high-dose, short-term intravenous streptokinase, the higher-dose intravenous regimen (1 million IU over 45 min) achieved thrombolysis in a significant minority (44%) of patients and might be useful therapy for patients not having access to emergency catheterization.

Adult↗

A randomised comparison of polydioxanone (PDS) and polypropylene (Prolene) for abdominal wound closure.

Two hundred and eighty four patients undergoing laparotomy by vertical incision were randomly allocated to closure with interrupted mass sutures of No. 1 polydioxanone (PDS) or No. 1 polypropylene (Prolene). Dehiscence occurred in 0.7% of the PDS group but in 6.4% of the Prolene group (P = 0.018). Wound infection occurred in 8.6% of the PDS group and 15.4% of the Prolene group (P = 0.1). One hundred and ninety patients attended for review at a minimum of one year. Incisional herniation, usually asymptomatic, was present in 11% of each group. Knots were palpable in 2% of the PDS patients but in 12% of the Prolene: wound pain occurred in 12% of the PDS group but in 23% of the Prolene group (P = 0.06). These results suggest that PDS may be useful for abdominal closure.

Abdomen↗

Continuous pleural infusion of bupivacaine offers better postoperative pain relief than does bolus administration.

BACKGROUND AND OBJECTIVES: To determine whether continuous pleural analgesia offers better postoperative pain relief than does bolus administration in postcholecystectomy patients. METHODS: Eighty postcholecystectomy patients with a subcostal incision were randomly allocated to receive pleural analgesia with either a bolus regime of 20 ml 0.375% bupivacaine with 1:200,000 epinephrine at four-hour intervals (bolus group), or a loading dose of 20 ml 0.375% bupivacaine with 1:200,000 epinephrine immediately followed by a continuous infusion at a rate of 6 ml/hour during the first 24 hours postoperatively (infusion group). A 10-cm linear visual analog scale was used and recorded before performing pleural analgesia and at 1,6,12,18, and 24 hours subsequently. Plasma levels of bupivacaine were determined in eight patients of the infusion group. Samples were taken at 5,15,30, and 60 minutes and at 6 and 18 hours after the start of infusion. RESULTS: Mean visual analog scale values were significantly lower (p less than 0.001) at 6, 12, 18, and 24 hours in the infusion group. PaCO2 decreased significantly (p less than 0.001) after the block in both groups, with no difference between the groups. Plasma levels were well below toxic levels in the infusion group. CONCLUSIONS: Continuous pleural analgesia offers better postoperative pain relief than does bolus administration. Pneumothorax was observed in two patients during the study.

Adult↗

Midline or transverse laparotomy? A random controlled clinical trial. Part I: Influence on healing.

Five hundred and seventy-nine patients undergoing major laparotomy were randomly allocated to have midline or transverse incisions. Transverse incisions took longer to make and caused more bleeding but (in the absence of wound sepsis) no transverse wound burst and there were only 2 incisional hernias. In the midline group, without wound sepsis, there were 2 burst abdomens and 9 incisional hernias. When, however, those patients who suffered wound sepsis were also considered, there were no significant differences between the two groups.

Aged↗

Effect of increasing amounts of epinephrine during isobaric bupivacaine spinal anesthesia in elderly patients.

The effects of adding epinephrine to isobaric bupivacaine spinal anesthesia were investigated in 96 ASA class II-III patients aged 75 yr or more scheduled for lower extremity surgery. The subjects were randomly allocated into six groups. All patients received 15 mg bupivacaine plain solution in 4 ml, in the horizontal position. Patients in group 1 received bupivacaine plus 1 ml normal saline; patients in other groups received bupivacaine plus increasing dosages of epinephrine: 0.1 mg (group 2), 0.2 mg (group 3), 0.3 mg (group 4), 0.4 mg (group 5), 0.5 mg (group 6). The segmental level of sensory loss was tested using forceps. The time required for maximal spread of the sensory blockade was significantly 50% greater in group 5 than in group 1. No difference was observed, however, between mean highest levels. Addition of 0.2 mg epinephrine prolonged by a significant 25% regression time to L-2 level. Addition of 0.3 and 0.4 mg epinephrine significantly prolonged two-segment regression time by 36 and 53%, respectively, and regression to L-2 level by 29 and 44%, respectively. Addition of 0.5 mg epinephrine did not result in further prolongation of anesthesia. Motor blockade was also increased by addition of epinephrine. It is concluded that addition of 0.3 mg epinephrine may be useful to increase duration of isobaric bupivacaine spinal anesthesia.

Aged↗

The effects of hormone replacement therapy type on pulmonary functions in postmenopausal women.

OBJECTIVE: To study whether hormone replacement therapy (HRT) or Tibolone has an effect on pulmonary function in postmenopausal women. METHODS: Seventy-five postmenopausal women without any risk factor for pulmonary disease were included in this randomized, prospective study. Fifty women had undergone natural menopause and 25 had had a hysterectomy/ooforectomy. Twenty-five natural menopause women were randomly allocated to two groups: 25 patients (Group I) were treated with Tibolone 2.5 mg/day, 25 patients (group II) with Estradiol Hemihidrate 2 mg+Norethindron Asetate 1 mg/day. Twenty-five induced menopause women were treated with 17 beta-estradiol 2 mg/day. Lung function tests including forced vital capacity (FVC), forced expiratory volume (FEV(1)), FEV(1)/FVC, forced expiratory flow rate over the 25-75% of the forced vital capacity volume (FEF(25-75%)), and peak expiratory flow rate (PEF) were evaluated at the beginning and 3 months after the treatment to assess the effects of HRT and Tibolone on respiratory function. RESULTS: Regardless of HRT types a significant difference was observed in FVC and FEV(1) after 3 months of the therapy (P=0.001, 0.0001, respectively). No significant difference was found between pre and post therapy values in the other parameters (P>0.05). CONCLUSIONS: We determined a significant increase in FVC and FEV(1) parameters of pulmonary functions after 3 months of the therapy regardless of HRT types. Therefore, we think that HRT regimens have modifying effects on pulmonary function in postmenopausal women.

Adult↗

A randomized double-blind study of the effects of two low-dose combined oral contraceptives on biochemical aspects. Report from a seven-centred study. WHO Special Programme of Research, Development and Research Training in Human Reproduction. Task force on Oral Contraceptives.

A comparative study of the metabolic effects of two combined oral contraceptive preparations was undertaken in seven WHO Collaborating Centres for Research in Human Reproduction. A total of 847 subjects were randomly allocated to one of two pill groups - norethisterone lmg/ethinyl estradiol 35 micrograms (NET/EE) or levonorgestrel 150 micrograms/ethinyl estradiol 30 micrograms (LNG/EE). An additional 195 women using an IUD served as a comparison group. Blood samples were taken on admission, and at 3 and 12 months thereafter. Both pills induced changes in fasting and 2-hour glucose, triglycerides, total cholesterol, HDL-cholesterol, bilirubin, alkaline phosphatase, albumin, and total protein, but not aspartate aminotransferase. The most dramatic and probably most clinically important changes were an increase in triglycerides and a decrease in HDL-cholesterol. The NET/EE preparation appeared to induce a greater increase in triglycerides, but no significant difference was found between the two pill preparations with respect to HDL-cholesterol changes.

Adult↗

A comparison of the effects of omeprazole and ranitidine on gastric secretion in women undergoing elective caesarean section.

This study compares the efficacy of omeprazole and ranitidine at reducing gastric secretion in obstetric patients. Sixty-five women scheduled to undergo elective Caesarean section under general anaesthesia were randomly allocated to receive either omeprazole 40 mg or ranitidine 150 mg orally at 2200 hours the night before and at 0600 hours on the morning of surgery. Intragastric pH and volume were measured immediately after induction of anaesthesia and on completion of surgery. All patients had gastric aspirates less than 25 ml. None of the omeprazole group had an aspirate of pH less than 3.5. Six patients (19%) in the ranitidine group had aspirates of pH less than 3.5, a significant difference from the omeprazole group (p less than 0.05). Of these six, two (6%) had aspirates of pH less than 2.5. Hence this study showed that omeprazole was more effective and consistent than ranitidine at maintaining gastric pH greater than 3.5.

Adult↗

Treatment of locally unresectable cancer of the stomach and pancreas: a randomized comparison of 5-fluorouracil alone with radiation plus concurrent and maintenance 5-fluorouracil--an Eastern Cooperative Oncology Group study.

One hundred ninety-one patients with pathologically confirmed, locally unresectable adenocarcinoma of the stomach (57 patients) and pancreas (91 patients), were randomly allocated to therapy with 5-fluorouracil (5-FU) alone, 600 mg/m2 intravenously (IV) once weekly, or radiation therapy, 4,000 rad, plus adjuvant 5-FU, 600 mg/m2 IV, the first three days of radiotherapy, then follow-up maintenance 5-FU, 600 mg/m2, weekly. Forty-three patients (22%) could not be analyzed because of ineligibility or cancellation, thus 148 patients were evaluable. The median survival time was similar for both treatment programs and for both types of primary carcinoma, and was as follows: gastric primary carcinoma, 5-FU, 9.3 months; 5-FU plus radiotherapy, 8.2 months; pancreatic primary carcinoma, 5-FU, 8.2 months; 5-FU plus radiotherapy, 8.3 months. Substantially more toxicity was experienced by patients treated with the combined modality arm than by those patients receiving 5-FU alone. Severe or worse toxicity experienced by patients with gastric primary carcinoma treated by 5-FU was 19%, and the combined modality arm was 31%. The toxicity experienced by patients with pancreatic primary carcinoma treated with 5-FU was 27%, and the combined modality arm was 51%. Significant prognostic variables included: weight loss in stomach-cancer patients; and performance status, degree of anaplasia, and reduced appetite in pancreas-cancer patients.

Adenocarcinoma↗

Myocardial contractility and performance capacity after magnesium infusions in young healthy persons: a double-blind, placebo-controlled, cross-over study.

To evaluate the effect of intravenous magnesium (Mg) treatment on the inotropic state of the heart and maximal work capacity, 9 healthy volunteers were entered in a double-blind, placebo-controlled, cross-over study. Separated by an interval of three weeks, the volunteers were tested twice, each time randomly allocated to receive either an intravenous injection of 10 mmol magnesium chloride dissolved in 100 ml isotonic sodium chloride or placebo of isotonic sodium chloride only. Before and after each infusion myocardial inotropism was evaluated by echocardiography. Mitral-septal distance (MSA) was used as a measure for ejection fraction. On each test day an ergometer bicycle exercise test was performed, and maximal work capacity was calculated. Magnesium treatment reduced the MSA (from 4.2 to 2.9 mm, p = 0.07), while no difference was found after placebo treatment. Likewise, a tendency toward increasing fractional shortening after magnesium treatment was detected, although this difference was not statistically significant (p = 0.1). No difference in maximal work capacity between the magnesium and placebo periods was found. Serum magnesium concentrations and placebo periods was found. Serum magnesium concentrations rose significantly after the infusions (from 0.82 to 1.38 mmol/l, p less than 0.001). It is concluded that intravenous magnesium does not exert a negative inotropic effect on the myocardium as previously stated. On the contrary, we found a tendency toward a positive inotropic effect. However, the observed differences are of borderline statistical significance and a more extended study, employing invasive measurements of cardiac inotropism appears to be necessary.

Adult↗

[Myocardial metabolism as affected by propofol in geriatric patients. A comparison with etomidate].

This study was designed to compare the effects of propofol and etomidate on myocardial metabolism in elderly patients without clinical manifestations of heart failure or coronary artery disease. Twenty geriatric patients (age 65-82 years) scheduled to undergo elective major upper-abdominal surgery were studied and randomly allocated to two equal groups (propofol and etomidate). All patients were premedicated with piritramide, 7.5 mg, and promethazine, 25 mg, intramuscularly 1 h before arrival in the anesthesia room. Ten patients received propofol (1.5 mg/kg) for induction of anesthesia, followed by 10-min infusion of an induction dose; thereafter, anesthesia was maintained with a continuous infusion of 0.1 mg/kg per min. Ten patients received etomidate, 18 mg, for induction, followed by 2.4 mg/min for maintenance. Vecuronium was used for neuromuscular blockade. Cardiovascular dynamics were recorded while the patients were awake, 1-2 min after induction during apnoea, and 1, 5 and 30 min after tracheal intubation without surgical stimulation. Coronary blood flow (argon wash-in technique with sampling of blood from the coronary sinus), myocardial oxygen consumption and myocardial uptake of glucose, free fatty acids and lactate were determined in the awake state and 5 and 30 min after intubation. Arterial plasma concentrations of propofol (high-pressure liquid chromatography with fluorescence detection) and etomidate (gas chromatography) were measured every 5 min throughout the investigation period, which lasted 45 min. Overall mean plasma concentrations of propofol were 3.69 +/- 0.16 micrograms/ml and of etomidate 1.1 +/- 0.16 microgram/ml.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗