Improving capacity assessments.
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Biomedical subjects
Publications and source records attributed to J Holzer.
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The main elements of the percutaneous spinothalamic tractotomy technique by the lateral approach are presented and the results obtained in 163 consecutive patients are communicated. We emphasize the importance of its early use in cases of intractable pain avoiding drug addiction. The simplicity of the method permits a less strict selection of the patients compared with the classic open cordotomy.
23 parkinsonian patients, 11 men and 12 women with an average age of 62 +/- 10 years, were recruited for an open substitution study of standard Madopar by Madopar HBS (hydrodynamically balanced system). All patients were presenting fluctuations in efficacy associated or not with abnormal involuntary movements. The patients in this study had been suffering from Parkinson's disease for 16 +/- 6 years and were severely disabled (Hoehn and Yahr grade III-V). The substitution was carried out dose for dose from one day to another. During the first month the dosage titration was aimed at finding the optimal therapeutic effect. After 120 days 13 patients were continuing the treatment while 10 had stopped it because of lack of therapeutic advantage. After 120 days, as compared to the initial state, end-of-dose fluctuations improved by 47%, the parkinsonian symptomatology by 54% and the abnormal involuntary movements improved by 33%. The daily dose of Levodopa had to be increased from 580 +/- 230 to 710 +/- 240 mg. The results obtained were excellent in 5 cases, good in 6 and moderate in 2 cases.
The rectal administration of midazolam for premedication of children before induction of anesthesia by mask was investigated in two clinical studies. In 62 children aged between 2 and 10 years, midazolam was given by open design at various dosages (0.15 mg.kg-1, 0.25 mg.kg-1, 0.30 mg.kg-1, 0.35 mg.kg-1, 0.40 mg.kg-1) to evaluate the most effective dose for optimal acceptance of the mask and gas mixture. An additional 40 children between 3 and 9 years received 0.2 mg midazolam.kg-1 body weight or placebo in a double-blind design to estimate the lower limit of efficacy of midazolam. All children were classified as ASA I and had to undergo a surgical procedure. Within the two studies the children were not different with respect to their general data, age, weight, and sex. In both studies more boys than girls were included. Parameters of efficacy were the degree of sedation before and at 10, 20, and 30 min after midazolam as well as acceptance of the mask and the gas mixture at induction of anesthesia. In all groups, including placebo, a sedative and tranquilizing effect of the premedication was found. The rectal administration of 0.35-0.4 mg midazolam.kg-1 is most suitable for the preoperative medication of children between 2 and 10 years. Due to the degree of sedation and the relief of anxiety toward the surroundings and the operation, the induction of anesthesia is optimally accepted by the child. In contrast, the effect of a dose around 0.2 mg midazolam.kg-1 body weight is not much different from that of placebo and is not sufficient for effective premedication.
Twenty-five patients, 12 men and 13 women, 42 to 79 years (mean 62) were studied to determine possible interest of a controlled release preparation of L. dopa combined with benserazide. All patients were experiencing fluctuations in efficacy over the last 8 +/- 4 years. Their Parkinson disease was of long duration, (16 +/- 5 years), severe (Hoehn and Yahr's stages III to V) and treated with L. dopa for 12 +/- 4 years. Results were evaluated in the short, medium and long term. During the initial period the new treatment was substituted for previous therapy on a dose for dose basis. Long term (300 days) results showed that "end of dose" fluctuations had been improved in 40 p. 100 of cases without concomitant reduction in therapeutic effects, duration of "ON" periods progressing by 60%. The frequency of drug intake was unaltered but daily dosage could be increased by 30% without increasing severity of abnormal movements to a similar degree. The administration of this new presentation can be recommended, especially when frequent fluctuations compromise long term therapeutic effects.
Changes in plasma histamine levels 2 min (t1) and 10 min (t2) after the intravenous injection of 0.2 mg X kg-1 midazolam were measured in 10 subjects at risk of releasing histamine (group I) and compared with those of 15 other subjects free from any risk of releasing histamine (group II). There was mean increases in plasma histamine levels of 0.78 ng X ml-1 between t0 and t1 (p less than 0.01), and of 0.41 ng X ml-1 between t0 and t2 (p less than 0.01) in group I; they only rose by 0.18 ng X ml-1 between t0 and t2 (p less than 0.01) in group II. The only statistically significant variation between the two groups was that at t1 (p less than 0.03): plasma histamine levels rose higher at the second minute in those cases at risk. This was a rather small increase, within physiological limits, and without any clinical or haemodynamic manifestation.
The haemodynamic effects of midazolam were compared with those of flunitrazepam in 10 patients with severe head injury under controlled ventilation. Right atrial pressure, pulmonary pressure, pulmonary capillary wedge pressure and cardiac output were measured using a Swan-Ganz thermodilution catheter. Arterial pressure (Pa) was recorded by radial arterial canulation. All patients in this cross-over study received midazolam (0.15 mg X kg-1) and flunitrazepam (0.02 mg X kg-1) intravenously randomly, with 24 h between the two injections. The measurements were first carried out before and then 5, 10, 20, 30 and 60 min after injection. The only significant variations after midazolam and flunitrazepam were a fall in Pa (from 93 +/- 12 to 81 +/- 11 mmHg for midazolam and from 89 +/- 14 to 78 +/- 20 mmHg for flunitrazepam) and in cardiac index (from 4.80 +/- 1.03 to 4.17 +/- 1.14 l X min-1 X m-2 for midazolam and from 5.18 +/- 1.32 to 4.54 +/- 1.03 l X min-1 X m-2 for flunitrazepam). The small decrease in heart rate was not significant. The cardiovascular changes after midazolam and flunitrazepam were small and similar for both drugs. It seemed that midazolam and flunitrazepam were safe for sedating head injured patients under controlled ventilation.
The object of this study was to determine the optimal dose of midazolam given per rectum which would produce sedation adequate for inducing inhalational anaesthesia in paediatric practice. Five doses were studied: 0.15, 0.25, 0.30, 0.35 and 0.40 mg X kg-1. The criteria used to appreciate the effectiveness of the sedation at 30 min were the change in the child's behaviour, with a scale of 6 levels, and the acceptance of the mask and anaesthetic vapours. There was a significant correlation between the dose administered and the degree of sedation, as well as between the dose administered and the lack of reaction to the mask. Significantly better results were found with the higher doses of 0.35 and 0.40 mg X kg-1, when compared with the children who had received 0.15 and 0.25 mg X kg-1. Only in the groups who received 0.35 and 0.40 mg X kg-1 were the degrees of sedation and acceptance of induction considered as adequate. The dose of 0.35 mg X kg-1 seemed to be the best dose for adequately premedicating a child.
A hypertensive patient with a history of diabetes and ischemic heart disease was given propranolol before ECT and experienced cardiac arrest after subconvulsive electrical stimulation. The authors suggest exercising caution when combining beta-adrenergic blockade and ECT.
The hypnotic effect of midazolam on the sleep of pre-surgical patients was studied in 99 patients (53 males, 46 females) due to undergo surgery the following day. One tablet of 15 mg midazolam was administered at 21.00 h and a second was given 45 min later if the subject had not fallen asleep, sleep-onset latency being measured from the time the second tablet was taken. Eighty patients required 1 tablet and 19 required 2 tablets. According to the subjective assessment, patients receiving 1 tablet fell asleep in 22.9 +/- 14.9 min and those taking 2 tablets fell asleep in 38.4 +/- 25.3 min (difference significant P less than 0.05). There was no statistically significant difference between the 1- and 2-tablet groups with regard to sleep duration, number of awakenings, overall assessment of the night's sleep, sleep quality and state on awakening. Factors which had a statistically significant influence on the dosage requirement were (a) sex, 30.4% females requiring a second tablet v. 9.4% males; (b) age, the mean age of the 2-tablet group being 36.5 v. 47 years in the lower dose group; (c) weight, patients with lower body weight requiring the higher dosage, mean 57.5 v. 66 kg; (d) current insomnia or a history of sleeping problems; (e) previous use of hypnotics; (f) degree of insomnia, moderate/severe insomnia needing a higher dosage (42% v. 21%).(ABSTRACT TRUNCATED AT 250 WORDS)
Three different dosage studies were carried out with midazolam in 47 institutionalized geriatric patients (17 males: mean age 82.9 years; 30 females: mean age 81.3 years) who were suffering from insomnia of long standing. Study I investigated the hypnotic efficacy of midazolam versus placebo in a double-blind, cross-over trial comparing the 7.5 and 15 mg doses of midazolam in 18 subjects. Both midazolam doses shortened sleep onset latency by 40 min (15 mg) and 31 min (7.5 mg). Both doses increased total sleep time compared with placebo. In study II, a comparative, cross-over trial in 10 subjects, an initial dose of 7.5 mg midazolam was sufficient to reduce the subjective appreciation of sleep onset time to less than 60 min on 66 of 70 study nights. Oxazepam (25 mg) had a comparable favourable effect but less frequently (53 of 70 nights). In study III, individual dose limits were investigated in 19 insomniac patients. The minimum effective dose was 7.5 mg. The maximum tolerated dose was in the range 15 to 52.5 mg according to the subjects' assessment. The most common optimum dose was 15 mg (10 of 19 patients). The higher doses prolonged sleep but midazolam appears to have a wide margin of safety as residual sedative effects appeared only after very high doses (four of 19 for 30 mg; eight of 19 for 37.5 mg). In some patients, 7.5 mg was the minimum dose that was effective in shortening sleep latency.(ABSTRACT TRUNCATED AT 250 WORDS)
Two groups of 27 individuals--12 males and 15 females each--were constituted thanks to the envelopes technique. The first group received 10 mg of midazolam and the second 15 mg of diazepam as an intramuscular premedication, 30 minutes before a surgical operation. Sedation of preoperatoire anxiety was relevant in 26 subjects after midazolam and in 11 after diazepam (p less than 0,001). Amnesia related to the different times of the operative procedure was more frequent in the midazolam group than in the diazepam group: 70 p. 100 versus 4 p. 100 for the arrival into the operating room (p less than 0,001) and 96 p. 100 versus 78 p. 100 for the recovery on operating table (p less than 0,05). The effects on blood pressure, pulse rate and respiratory rate are not significantly different in both groups: neither is the local and general tolerance. Considering its greater efficiency with a similar tolerance, midazolam as compared with diazepam can be regarded as a superior intramuscular premedicant.
In order to determine the optimal posology of midazolam as an intramuscular premodication according to age, three groups of 25 patients were constituted. The mean age of group 1 receiving 0.12 mg . kg-1, was 31.6 +/- 7.3 years, the mean age of group 2, receiving 0.16 mg . kg-1, was 31.8 +/- 7.6 years and the mean age of group 3, receiving 0.10 mg . kg-1, was 73.8 +/- 8.2 years. The results were the following: sedation of anxiety was good or very good in respectively 80 p. 100 and 95 p. 100 of patients in groups 2 and 3, versus 48 p. 100 in group 1; a reversible sleep was obtained in 18 p. 100 of cases in group 2 and 44 p. 100 in group 3; no patient was asleep in group 1; overall clinical results were found satisfactory in 80 p. 100 of patients in group 2, and 95 p. 100 in group 3 versus 48 p. 100 in group 1. Neither incident nor adverse reactions were to be reported. There was no modification in respiratory rate; the slight hemodynamic modifications which appeared can be attributed to atropine sulfate administered together with midazolam. In conclusion, the appropriate posology of midazolam administered intra-muscularly decreases with age, from 0.16 mg . kg-1 for the thirty years old patients to 0.10 mg . kg-1 for the seventy years old patients. Midazolam exhibits a remarkable cardiorespiratory neutrality event in the elderly.
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