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At least 91 records · Page 5Linked to original sources

A multicenter international controlled comparison of two dosage regimes of misoprostol and cimetidine in the treatment of duodenal ulcer in out-patients.

In this double-blind parallel group multicenter international study, patients with endoscopically proven acute duodenal ulcers were allocated randomly to treatment for four weeks with either misoprostol 50 micrograms, misoprostol 200 micrograms or cimetidine 300 mg, each given q.i.d.. Endoscopic, clinical and laboratory assessments were made prior to and after four weeks' treatment. A clinical assessment was also made at two weeks. 703 patients were recruited. The three treatment groups were similar with regard to age, sex and occupation. Therapeutic success was defined as complete healing of all ulcers on the basis of an endoscopic examination. On an intent to treat basis, which includes all losses to follow-up and withdrawals as treatment failures, the cure rates in the misoprostol 50 micrograms, misoprostol 200 micrograms and cimetidine groups were 41%, 60% and 67% respectively. There was no statistically significant difference between the misoprostol 200 micrograms and the cimetidine 300 mg groups (P = 0.11). Both were significantly better than the low dose misoprostol group (P less than 0.001). All three treatments were well tolerated and severe adverse events were rare.

Adolescent↗

Randomised trial of community-based centre versus conventional hospital management in treatment of alcoholism.

151 problem drinkers (105 men and 46 women) were recruited from the general medical and psychiatric services of a district general hospital and were allocated randomly to a community-based day centre (ACCEPT) or standard hospital inpatient and outpatient services. 115 patients (79%) were followed up at 12 months. The group as a whole showed improvement in all outcome indices at the 3-month follow-up, and this was maintained at 6 and 12 months. Patients assigned to ACCEPT services claimed to have reduced their alcohol intake (55%) more than their hospital counterparts (37%), and this was confirmed by their informants. Patients referred from the psychiatric services reduced their alcohol intake more than those from general medical services. It is concluded that treatment at a community day centre is at least as cost effective as hospital treatment of alcohol abuse.

Adolescent↗

Continuous extradural infusion of 0.125% bupivacaine for pain relief after lower abdominal surgery.

Twenty women, undergoing lower abdominal surgery, were allocated randomly to receive a continuous extradural infusion of either 0.125% bupivacaine or placebo at a rate of 15 ml h-1. All had received an intra-operative extradural block. Pain scores were recorded at 30, 60, 90, 120, 150, 180, 240 and 360 min after surgery. From 150 min onwards there was a significant benefit for those receiving the active drug. Six of nine patients in this group had adequate analgesia over the 6-h study period, while all patients in the placebo group required further pain relief.

Abdomen↗

No effect of continuous i.p. infusion of bupivacaine on postoperative analgesia, pulmonary function and the stress response to surgery.

In a double-blind prospective study, 20 patients undergoing major abdominal surgery were allocated randomly to receive a continuous 8-h i.p. infusion of either physiological saline or 0.25% bupivacaine 20 ml h-1 (in saline) following a loading dose of saline 1 ml kg-1 or 0.25% bupivacaine 1 ml kg-1 on entering the peritoneum. The following variables were measured before and at 2-h intervals during the infusion: serum glucose and cortisol concentrations, forced vital capacity, forced expiratory volume in the first second, peak expiratory flow rate and pain at rest, on mobilization and on coughing (visual analogue scale). Postoperative pain, impairment in pulmonary function and increase in serum cortisol and glucose concentrations were not influenced by the i.p. infusion of bupivacaine when compared with saline. This study shows that the i.p. instillation of therapeutically safe doses of bupivacaine was without effect in the management of pain, postoperative pulmonary dysfunction and the stress response in this group of patients.

Abdomen↗

Local analgesia prevents the cortisol and glycaemic responses to cataract surgery.

We studied the metabolic and hormonal responses to cataract surgery in 18 elderly patients, allocated randomly to receive either general anaesthesia or local analgesia by means of a retrobulbar block. Local analgesia prevented the increases in circulating cortisol and glucose concentrations found in those patients who received general anaesthesia. The results show that complete afferent sensory block of the operative site inhibited endocrine and metabolic responses to ophthalmic surgery.

Aged↗

Pupillary effects of alfentanil and morphine.

We have measured the onset and extent of the miotic effect of morphine and alfentanil in conscious patients. Forty unpremedicated ASA I and II patients were allocated randomly to four groups to receive either i.v. saline (control group), morphine 0.1 mg kg-1, alfentanil 4.0 micrograms kg-1 or a combination of these doses, and pupil diameters were measured for the next 30 min. There were no significant differences in the control diameters. In the opioid groups, a significant decrease in diameter (about 1 mm), occurred 4 min after administration of the drug and persisted throughout the study. The opioid groups behaved similarly for 25 min. After 10 min the mean diameter of the alfentanil group began to increase, but this did not reach statistical significance until after 25 min.

Adult↗

Effect of the laryngeal mask airway on lower oesophageal sphincter pressure in patients during general anaesthesia.

We have studied the tone of the lower oesophageal sphincter (LOS) in 40 adults undergoing routine body surface surgery and allocated randomly to receive anaesthesia either by face mask and Guedel airway or by laryngeal mask airway. In the laryngeal mask group there was a mean (SEM) decrease in barrier pressure (LOS minus gastric pressure) of 3.6 (1.4) cm H2O, compared with a mean increase of 2.2 (1.2) cm H2O in the face mask group (P < 0.005).

Adult↗

Effect of epidural clonidine on analgesia and pharmacokinetics of epidural fentanyl in postoperative patients.

Epidural clonidine produces postoperative analgesia in patients and potentiates opioid analgesia in animals. The aim of the current study was to assess the effect of epidural clonidine on the plasma concentrations and analgesic effect of fentanyl after epidural administration. Twenty ASA physical status 2 or 3 patients recovering from abdominal surgery were allocated randomly to receive either epidural fentanyl (100 micrograms in 10 ml isotonic saline; EF group) or epidural fentanyl (same dose) plus epidural clonidine (150 micrograms; EF + C group) in isotonic saline solution. Analgesia was assessed over a period of 12 h after epidural injection. Venous samples were obtained until 360 min after epidural injection for radioimmunoassay determination of plasma fentanyl concentration. Onset of analgesia was similar in the two groups of patients (13 +/- 6 and 13 +/- 3 min, respectively, after injection), but duration was more than doubled in the patients receiving clonidine (543 +/- 183 vs. 250 +/- 64 min). Peak plasma fentanyl concentrations (Fmax) and the time to reach Cmax (Tmax) were comparable in the two groups (0.29 +/- 0.15 ng.ml-1 at 16.2 +/- 14.8 min in the EF group and 0.27 +/- 0.11 ng.ml-1 at 8.3 +/- 5.5 min in the EF + C group), as were plasma concentrations at each definite time of measurement. Drowsiness and hypotension were noticed in the EF + C group. Thus, epidural clonidine appears to prolong epidural fentanyl analgesia without affecting its plasma concentration.

Aged↗

Mitomycin C as an adjuvant in resected gastric cancer.

As a result of their previous experience with mitomycin C at high discontinuous doses in advanced gastric cancer, the authors studied its role as an adjuvant for locally advanced cases after surgical complete resection. Results from 70 evaluable patients are presented. Patients were allocated randomly to receive mitomycin C, 20 mg/m2 I.V. direct once every 6 weeks, four courses, or a placebo. After a follow-up period of 250 weeks, seven patients of treatment arm and 23 controls have already relapsed (p less than 0.001). Toxicity was moderate and controllable by symptomatic measures. The authors consider this investigation a positive contribution in the field of adjuvant therapy of gastric cancer.

Actuarial Analysis↗

Effects of beta-adrenoceptor antagonism on the cardiovascular and catecholamine responses to tracheal intubation.

The catecholamine and cardiovascular responses to laryngoscopy and tracheal intubation were studied in 20 patients who underwent elective gynaecological surgery and who were allocated randomly to receive either practolol 10 mg or saline intravenously prior to induction of anaesthesia. Anaesthesia was induced with fentanyl and thiopentone; atracurium was administered and the lungs were ventilated artificially with 67% nitrous oxide in oxygen. Tracheal intubation was performed when muscle relaxation was adequate. Arterial pressure, heart rate, plasma noradrenaline and adrenaline concentrations were measured before and after tracheal intubation. A significant increase in catecholamine concentrations occurred in both groups in response to tracheal intubation but the magnitude of the increase in adrenaline was greater in the practolol group. There were no significant differences in arterial pressure or heart rate changes between the groups. We conclude that pretreatment with practolol is of no value in the attenuation of the hypertensive response to direct laryngoscopy and tracheal intubation in previously normotensive patients.

Adult↗

Comparison of anxiety before induction of anaesthesia in the anaesthetic room or operating theatre.

Anxiety before induction of anaesthesia was studied in 100 patients who were allocated randomly to one of two groups. Patients in one group were anaesthetised in an anaesthetic room and those in the other group were anaesthetised inside the operating theatre. Both subjective and objective induces of anxiety were used in the comparison. Other factors that contributed to anxiety were assessed by a simple questionnaire. There was no significant difference in the level of anxiety between the two groups. The site of induction did not emerge as a major contributory factor to anxiety. The advantages and disadvantages of anaesthetic rooms are discussed.

Adolescent↗

A comparison of the effects of alfentanil/droperidol or fentanyl/droperidol on intra-ocular pressure.

The influence of two intravenous sedative regimens on intra-ocular pressure was investigated in conjunction with retrobulbar local anaesthesia. Forty patients were allocated randomly to either group A (alfentanil and droperidol) or group F (fentanyl and droperidol). Measurements of intra-ocular pressure, arterial pressure and oxygen saturation were made before operation, after premedication, after intravenous sedation and after surgery. Paco2 was also measured before and after operation. Each sedation technique caused a similar reduction in intra-ocular pressure. There was less effect on Paco2 and oxygenation in group A.

Aged↗

Tussive effect of a fentanyl bolus administered through a central venous catheter.

One hundred and ten male patients scheduled for coronary artery bypass grafting were allocated randomly into one of three groups. Patients in group A received fentanyl 7 micrograms/kg via a central venous catheter, those in group B were given fentanyl 7 micrograms/kg through a peripheral venous cannula, and patients in group C received sterile water via a central venous catheter. In group A, 45.9% of patients coughed after injection of fentanyl; the mean onset time from the end of fentanyl administration to the beginning of coughing was 10.6 seconds. Only one patient in group B and no patient in the control group exhibited a cough response (p less than 0.0001). We hypothesise that fentanyl can evoke the pulmonary chemoreflex.

Catheterization, Central Venous↗

Is crystalloid preloading useful in spinal anaesthesia in the elderly?

Sixty ASA grade 1 or 2 patients, aged 60 years or over, scheduled for surgery to the lower abdomen or lower limbs under spinal anaesthesia were allocated randomly to one of three treatment groups. Group A received 16 ml/kg of Ringer's acetate solution immediately before spinal anaesthesia, group B received 8 ml/kg and group C received no volume preload. Heart rate, arterial pressure and anaesthetic level were recorded by an independent observer. The overall incidence of systemic arterial hypotension (defined as a decrease of 25% or more in systolic arterial pressure) was 27%; there were no significant differences among groups. The overall incidence of hypotension was 60%, when temperature sensation was blocked to T7 and above (n = 25). The number of patients with hypotension which required treatment increased as block height increased above T7; at a level of T4 or higher, all patients required ephedrine. Crystalloid preloading had no effect on the incidence of hypotension after spinal anaesthesia in fit, elderly patients.

Aged↗

Itraconazole therapy in pityriasis versicolor.

The efficacy of itraconazole was assessed in an open trial in 30 patients with disseminated lesions of pityriasis versicolor confirmed by direct microscopy. The patients were allocated randomly to one of two treatment regimens, 200 mg once daily for 5 days or 100 mg once daily for 10 days. On assessment 3 weeks after the end of the treatment, 25 patients were healed, two patients had mild residual lesions, two had considerable residual lesions and one patient had relapsed. One patient reported dyspepsia and one patient reported stomach ache. One patient had asymptomatic elevation of serum transaminase (GOT and GPT) but this had returned to normal 3 weeks after the end of therapy.

Adolescent↗

A double-blind trial of the H2 receptor antagonist cimetidine, and the H1 receptor antagonist promethazine hydrochloride in the treatment of atopic dermatitis.

Twenty young adults with atopic dermatitis were allocated randomly in a clinical trial to compare the action of the H2 receptor antagonist cimetidine (Tagamet) and the H1 receptor antagonist promethazine hydrochloride (Phenergan), singly and in combination. No significant differences were found, clinically or in the laboratory investigations, between the patients on either drug alone or the combination of the two.

Adolescent↗

Fat emulsion adversely affects lymphocyte reactivity.

Although nutritional repletion of malnourished individuals may improve tests of cell-mediated immunity, the effects of intravenous nutrient solutions themselves on the immune system are largely unknown. This study examined the effects of five parenteral nutrition solutions on in vitro lymphocyte reactivity and measured lymphocyte responsiveness in patients receiving parenteral nutrition. Normal human lymphocytes were incubated with dilutions of an amino acid/dextrose solution, an amino acid/dextrose/fat solution, an amino acid solution, dextrose, and a fat emulsion, and lymphocyte responsiveness to antigenic (PPD) and mitogenic (PHA) stimulation was measured using an in vitro electrophoretic test of cell-mediated immunity. Lymphocyte reactivity was measured in 15 postoperative patients allocated randomly to receive either simple electrolyte solutions or isocaloric parenteral regimes with or without a fat emulsion. In vitro lymphocyte responses were significantly depressed (P less than 0.001) by the fat emulsion at concentrations similar to those achieved in clinical practice but were unaffected by dextrose or amino acid solutions. Lymphocyte reactivity was significantly depressed in patients during infusion of the fat emulsion in comparison with controls (P less than 0.05). The results show that fat emulsion impairs lymphocyte reactivity and suggest that careful consideration should be given before using fat emulsions in patients in whom cell-mediated immunity is impaired already.

Clinical Trials as Topic↗

Heart disease prevention project: a randomised controlled trial in industry.

Twenty-four factories or other occupational groups, employing 18 210 men aged 40 to 59, were formed into matched pairs. One of each pair was allocated randomly to receive a five to six year programme of medical examinations and intervention to reduce the levels of the main coronary risk factors. Men at factories in the intervention group were given advice on dietary reduction of plasma cholesterol concentrations, stopping or reducing cigarette smoking, regular exercies for the sedentary and reduced energy intake for the overweight, and hypertension was treated. The programme was delivered mainly through existing occupational medical services, helped by a small central staff. Personal consultations were largely confined to men with a high risk of developing coronary heart disease. Changes in risk factors were assessed by regular standardised examinations of random samples of men. The spread of information by general propaganda proved easy, but a change in habits seemed to require personal contact. Small but significant reductions occurred, mainly in the high-risk group, but these were not sustained when pressure was relaxed.

Adult↗