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PubMed1994

The sedative effects of intranasal midazolam administration in the dental treatment of patients with mental disabilities. Part 2: optimal concentration of intranasal midazolam.

In a previous paper, we reported on the effect of a 0.2 mg/kg dose of midazolam, administered intranasally, prior to performing various restorative dental procedures on a group of mentally disabled patients under local anesthesia and nitrous oxide/oxygen analgesia. The purpose of this study was to compare the clinical and possible adverse effect of doses of 0.2 mg/kg and 0.3 mg/kg midazolam, administered intranasally, and to determine the most appropriate concentration for the drug when administered by this route. Patients were assessed by a behavioral test which consisted of a scale from 1-7 with 3 ranges: markedly effective (1-3), effective (4-5) or ineffective (6-7). Forty-three mentally handicapped patients, aged 5 to 20 years, all of whom had previously exhibited highly combative and resistant behavior toward dental treatment under local anesthesia, were stratified by age and randomly assigned in a double blind manner to two groups, receiving either 0.2 mg/kg or 0.3 mg/kg midazolam administered intranasally. Group 1, consisting of 22 patients, average age 11 years 8 months, received 0.2 mg/kg. Group 2 consisted of 21 patients, average age 13 years 8 months, each of whom was administered 0.3 mg/kg intranasal midazolam. Only patients assessed as ASA anesthesia status I or II were admitted to the study. Subsequent to intranasal administration of midazolam, no patient rejected the nasal mask nor refused to inhale nitrous oxide/oxygen. The induction of nitrous oxide/oxygen sedation and oral examination were effected smoothly in every case in the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intranasal↗
PubMed2006

Atmospheric pressure desorption/ionization on silicon ion trap mass spectrometry applied to the quantitation of midazolam in rat plasma and determination of midazolam 1'-hydroxylation kinetics in human liver microsomes.

The application of atmospheric pressure desorption/ionization on silicon (AP-DIOS) coupled with ion trap mass spectrometry (ITMS) was investigated for the quantification of midazolam in rat plasma, and determination of midazolam 1'-hydroxylation kinetics in pooled human liver microsomes. Results indicate good sensitivity with absolute detection limits for midazolam in rat plasma of approximately 300 femtograms. A linear dynamic range from approximately 10-5000 ng/mL was obtained in rat plasma with analysis times of 1 min per sample. Kinetic constants for midazolam 1'-hydroxylation in human liver microsomes yielded an apparent Km of 10.0 microM and Vmax of 6.4 nmol/min/mg. Studies investigating the inhibition of 1'-hydroxymidazolam formation by the cytochrome P450 3A4 model inhibitor ketoconazole yielded an IC50 of 0.03 microM. Quantitative precision for replicate analysis of rat plasma and human liver microsomal samples was variable with relative standard deviation (RSD) values ranging from a low of approximately 3% to over 50%, with the highest variability observed in data from human liver microsomal incubations. While preliminary studies investigating the application of AP-DIOS-ITMS suggested feasibility of this technique to typical pharmacokinetic applications, further work is required to understand the underlying causes for the high variability observed in these investigations.

Animals↗
PubMedDate not supplied

Reversal of central benzodiazepine effects by intravenous flumazenil after conscious sedation with midazolam and opioids: a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group II.

The efficacy and safety of flumazenil in antagonizing the central effects of the benzodiazepine midazolam was demonstrated in patients in whom conscious sedation was induced with midazolam plus an opioid (fentanyl, meperidine, or morphine). In a double-blind, multicenter study, 240 patients were administered flumazenil postoperatively at an average intravenous dose of 0.7 mg (7 ml) and 114 patients were administered an average dose of 9 ml placebo. Complete reversal of sedation was observed in 80% of flumazenil-treated patients and 30% of placebo-treated patients 5 minutes posttreatment. In 87% of patients who responded to flumazenil, the level of alertness was maintained throughout the 180-minute observation period. Midazolam-impaired psychomotor performance returned to normal 5 minutes posttreatment in 80% of the flumazenil-treated patients and 28% of the placebo-treated patients. Flumazenil was less effective in reversing midazolam-induced amnesia, with only 70% of flumazenil-treated patients (and 15% of placebo-treated patients) able to recall the picture shown them at the 5-minute assessment, and fewer patients able to recall pictures shown at later times. Flumazenil was well tolerated, although adverse effects were reported slightly more often than in the placebo group. The most frequent adverse events in both groups were dizziness and nausea. Vital signs were not affected.

Adolescent↗
PubMedDate not supplied

Comparison of the efficacy of oral midazolam alone versus midazolam and meperidine in the pediatric dental patient.

PURPOSE: The purpose of this study was to compare midazolam alone (Group A: 1 mg/kg) vs midazolam plus meperidine (Group B: 0.5 and 1 mg/kg, respectively) in regard to physiology and behavior of young children sedated for dental restorative care. METHODS: Twenty healthy children who met selection criteria were randomly assigned to 1 of 2 groups and subsequently treated in a prospective, crossover design. All sedative agents were administered orally, and all sedations included 50% nitrous oxide administered via a nasal hood. Heart rate, systolic and diastolic blood pressure, and behavior were recorded at 8 procedural or time periods during the visits. Chi-square and ANOVA were used to analyze the data. RESULTS: No difference in physiology or behavior was found between groups. However, higher heart rates and disruptive behaviors occurred more frequently during or after local anesthesia administration. CONCLUSIONS: Oral midazolam alone is just as effective as midazolam with meperidine. Disruptive behaviors accounted for increased heart rates.

Administration, Oral↗
PubMedDate not supplied

Parametric evaluation of methotrimeprazine-midazolam-ketamine and methotrimeprazine-midazolam-ketamine-xylazine combination in dogs.

PURPOSE: To evaluate the parameters of dogs anesthetized by different dissociative drugs protocols through continuous intravenous infusion. METHODS: Thirty healthy dogs of both sexes were assigned randomly to three groups (G1, G2, and G3). G1 was administered with methotrimeprazine as a pre-anesthetic medication, intravenously midazolam-ketamine as bolus for induction and midazolam-ketamine by continuous intravenous infusion for a 60 minute-period of maintenance. G2: the same as for G1. plus an increase in the midazolam dose during maintenance. G3: the same treatment as for G2, plus the addition of xylazine during maintenance. Immediately after induction the anesthetic maintenance started, and measures were taken 15 minutes after pre-medication, at 10 minutes intervals, during maintenance (M0 to M7). RESULTS: Bradycardia, atrioventricular blockage, bradypnea and hypoxemia were shown in G3. G1 and G2 showed a slight hypotension only. CONCLUSION: There were some advantages by using the continuous intravenous via: no parameters oscillation and reduction in the anesthetic recovery period. The increase in midazolam dose brought about little parametric variations which were greater when xylazine was used, with a consequent hypoxemia, bradyarrhytmia, and decrease in respiratory frequency and minute volume.

Anesthesia Recovery Period↗
PubMed1995

[Acceptability of high colonoscopy using different premedication--a comparison of the effect of midazolam versus midazolam and pethidine from the viewpoint of the patient and the physician].

Invasive endoscopic procedures such as total colonoscopy result in a better patient acceptance, the less discomfort they cause. Therefore a premedication for total colonoscopy is often required. In a prospective, double-blind, placebo-controlled clinical study of 132 patients examined by one experienced endoscopist we compared two premedication schedules: midazolam (mean 5.2 mg i.v.) versus midazolam (mean 4.8 mg) plus pethidin (50 mg). We found that the combination midazolam plus pethidin provides a deeper and more reliable sedation and analgesia than midazolam alone. The combination of both drugs caused also more anterograde amnesia. It was also shown, that the endoscopist scored a higher degree of patient's pain during the examination than the patient did himself. No more negative side-effects such as decrease of arterial partial pressure of oxygen or cardiopulmonary complications were found using the combination of both drugs; they provided to be safe without added risk of hypoxia. Thus, the combination of both drugs can be given as premedication for total colonoscopy.

Adolescent↗
PubMed1982

Determination of midazolam and two metabolites of midazolam in human plasma by gas chromatography--negative chemical-ionization mass spectrometry.

A method is described for measuring midazolam, a new anesthesia induction agent and hypnotic, and its hydroxymethyl and desmethyl metabolites in human plasma. Deuterated analogues of each compound are added to plasma as internal standards. The compounds are extracted from plasma with benzene containing 20% 1,2-dichloroethane and after removal of the extracting solvent are dissolved in a solution of bis-(trimethylsilyl)acetamide and acetonitrile. An aliquot of this solution is analyzed by gas chromatography--mass spectrometry with the mass spectrometer set to monitor in the gas chromatographic effluent the M.- ions of drug, metabolites and internal standards generated by methane electron-capture negative chemical ionization. For all three compounds, the limit of quantitation is 1 ng ml-1, and the precision (relative standard deviation) at a concentration of 5 ng ml-1 is less than 6%. Measurable amounts of the hydroxymethyl, but not the desmethyl, metabolite of midazolam could be found in the plasma of humans given either an intravenous or an oral dose of midazolam maleate.

Adult↗
PubMed1991

Antagonism of the hypnotic effect of midazolam in children: a randomized, double-blind study of placebo and flumazenil administered after midazolam-induced anaesthesia.

In a randomized, double-blind study, we administered placebo and flumazenil to 40 healthy Chinese boys, aged 3-12 yr, undergoing circumcision. The children received midazolam 0.5 mg kg-1 orally for premedication and 0.5 mg kg-1 i.v. during induction. After operation the patients were given 0.1 ml kg-1 of a blinded solution followed by 0.05 ml kg-1 min-1 until either they awoke or the 10-ml ampoule of solution was empty. Efficacy of antagonism of midazolam was assessed by times to eye opening and self identification, modified Steward coma scale, a post-box toy completion-time ratio and qualitatively by an independent observer. The difference between flumazenil and placebo was both clinically and statistically different in the first 2 h. Children receiving flumazenil awoke approximately four times faster and identified themselves nearly three times sooner; 65% of this group could complete the post-box toy at 10 min, compared with none of the placebo group. There were no cases of resedation, but one child did not awaken for 30 min after i.v. administration of flumazenil 1.0 mg. The mean total dose of flumazenil administered was 0.024 (SD 0.019) mg kg-1. Flumazenil rapidly antagonized midazolam-induced hypnosis in children and was associated with minimal change in cardiorespiratory variables.

Anesthesia Recovery Period↗
PubMed1997

Comparison of the effects of ketamine-midazolam with those of fentanyl-midazolam on cortical somatosensory evoked potentials during major spine surgery.

Cortical somatosensory evoked potentials (CSEP) allow monitoring of spinal cord function during surgery. Ketamine has been shown to enhance CSEP amplitude, but there is no previous study comparing its effects with those of other anaesthetic regimens. Therefore, we have compared the effects of ketamine with those of fentanyl, both combined with midazolam, on CSEP monitoring during major spine surgery. Twenty patients with normal preoperative CSEP were allocated randomly to a ketamine or fentanyl group. Anaesthesia was induced with ketamine 3 mg kg-1 or fentanyl 6 micrograms kg-1 i.v., and midazolam 0.3 mg kg-1 i.v in both groups, and maintained with continuous i.v infusion of ketamine 2 mg kg-1 h-1 or fentanyl 3 micrograms kg-1 h-1, combined in both groups with midazolam 0.15 mg kg-1 h-1 and 60% nitrous oxide in oxygen. CSEP were elicited by tibial posterior nerve stimulation and measured P1 and N1 latencies, and P1-N1 amplitude, CSEP were recorded before and after induction, at 15 min, 1 and 2 h after induction, during skin closure and after removal of nitrous oxide. Both groups were comparable in characteristics, duration of surgery, mean arterial pressure and temperature. CSEP latencies were not significantly affected in either group. CSEP amplitude decreased significantly over time in the fentanyl group (from mean 2.02 (SEM 0.41) to 0.95 (0.17) microV, P < 0.05), but not in the ketamine group (from 1.33 (0.36) to 1.05 (0.31) microV, ns). Nevertheless, we did not observe any significant differences in amplitudes or latencies between the two groups. The delay in obtaining the first voluntary postoperative motor response was significantly greater in the ketamine group (170 (54) vs 55 (17) min, P < 0.01). Both ketamine and fentanyl allowed us to obtain reliable CSEP during major spine surgery, and there were no significant difference between these two anaesthetic regimens for CSEP monitoring, but a longer delay for voluntary postoperative motor assessment was observed in the ketamine group.

Adult↗
PubMed1986

Midazolam-fentanyl anesthesia for major surgery. Plasma levels of midazolam during prolonged total intravenous anesthesia.

The water-soluble benzodiazepine midazolam was used along with fentanyl and pancuronium in a totally intravenous anesthetic technique for hysterectomies. Midazolam was given as a 0.3 mg X kg-1 bolus dose followed by constant rate infusion of 0.25 mg X kg-1 X h-1. Plasma midazolam concentrations were measured during the anesthesia. The technique provided excellent conditions for surgery, with pulse rate and blood pressure under good control and without any recall of the peri-operative period. A disadvantage was early respiratory depression, which necessitated administration of naloxone to make extubation possible. This was attributed to the proportionally large amount of fentanyl used. Drowsiness during the first postoperative hours was also pronounced.

Adult↗
PubMed1995

Cardiopulmonary effects of medetomidine, medetomidine-midazolam and medetomidine-midazolam-atipamezole in dogs.

Cardiopulmonary effects of medetomidine (20 micrograms/kg)-midazolam (0.3 mg) (Me-Mi) were compared with those of medetomidine alone (80 micrograms/kg) (Me80) in dogs. The intramuscular administration of this combination caused bradycardia and transient mild pressor response. Heart rate decreased soon after the administration and remained significantly below the baseline value with average values of 50-70 beats/min. Blood pressure increased to its maximum within 5 to 10 min then decreased gradually. Cardiac index decreased corresponding the decrease in heart rate. However these changes were less profound than those of Me80 indicating significantly higher values in cardiac index and lower values in systemic vascular resistance. Effects on the respiratory function were slight. The reduction of the dose of medetomidine to one-fourth in Me-Mi was effective to reduce the adverse effect of medetomidine, especially in peripheral vasoconstriction. Atipamezole effectively reversed cardiopulmonary effects induced by medetomidine-midazolam. Heart rate and cardiac index increased and systemic vascular resistance decreased significantly after administration of atipamezole. The possible use of an antagonist as a reversal agent might enhance the value and availability of medtomidine-midazolam as a chemical restraint agent in dogs.

Adrenergic alpha-Antagonists↗
PubMed1998

Observations on the use of midazolam for sedation, and induction of anaesthesia with midazolam in combination with ketamine in the goat.

Midazolam hydrochloride administered intramuscularly at a dosage of 0.4 mg/kg induced sedation and sternal recumbency in goats. Increasing the dosage to 1 mg/kg resulted in rapid onset of ataxia followed by lateral recumbency, and loss of consciousness. Light surgical anaesthesia lasted for a period of 7-15 min and was suitable for non-painful procedures. Heart rate was significantly increased (p < 0.05) at both dosage rates, while respiration rate was only increased after midazolam at 0.4 mg/kg. The combination of midazolam (0.4 mg/kg) and ketamine hydrochloride (4 mg/kg) increased heart and respiration rate significantly (p < 0.05). A light plane of surgical anaesthesia suitable for endotracheal intubation was induced, which lasted for a period of 16-39 min.

Analgesics↗
PubMedDate not supplied

Reversal of central nervous system effects by flumazenil after intravenous conscious sedation with midazolam: report of a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group I.

Flumazenil, a benzodiazepine antagonist, reverses the residual central nervous system effects of benzodiazepines. In this US double-blind, multicenter study, the efficacy of flumazenil was compared with that of placebo in antagonizing the effects of midazolam, a benzodiazepine used to induce intravenous conscious sedation. The mean dose of flumazenil was 0.7 mg, administered intravenously. At 5 minutes posttreatment, 82% of 131 flumazenil-treated patients, compared with 15% of 65 placebo-treated patients, demonstrated complete reversal of sedation. In 85% of patients who responded to flumazenil, this reversal of sedation was maintained throughout the 180-minute observation period. Psychomotor performance returned to prestudy levels 5 minutes posttreatment in 87% of the flumazenil-treated patients, compared with 28% of the placebo-treated patients. At the doses administered, flumazenil was less effective in reversing midazolam-induced amnesia, with only 60% of patients demonstrating partial recovery of memory. It was, nevertheless, more effective than placebo. Flumazenil was well tolerated. Dizziness (10%) and nausea (9%) were the most frequently reported adverse effects. Results of this study demonstrate that flumazenil antagonizes the central nervous system effects of midazolam after intravenous conscious sedation.

Adolescent↗
PubMed1992

[Optimal dose of midazolam as premedicant for combined spinal and epidural anesthesia with midazolam sedation].

Sixty patients who underwent simple total hysterectomy under combined spinal and epidural anesthesia with midazolam sedation, were the subjects of a randomized double-blind comparison of intramuscular midazolam 4, 4.5 and 5 mg, and a dose determined by body weight as premedicants. Similar changes in arterial pressure and heart rate were observed. Furthermore sedation and the value of pulse oximetry on arrival were the same. Besides half the patients were amnesic during the procedure of regional approach. However the dose of premedicant was inversely correlated with the maintenance dose. The reduction of pulse oximetry reading on the induction was smaller, while the requirement of vasopressor occurred earlier following the larger dose of premedicant. In spite of the slower induction, the fall of pulse oximetry reading did not decrease. One hour after incision, the reduction of PaO2 was not dose related. In addition count of leucocyte and the level of blood glucose were unchanged. Premedicant determined by body weight was not correlated with the induction dose and amnesic effect. Our findings suggest midazolam 5 mg intramuscularly is the more preferable dose, but careful attention on arterial pressure is required.

Adult↗
PubMed2006

[Hemodynamic, immunologic and systemic stress response during surgery under total intravenous anesthesia with midazolam-ketamine-fentanyl or remifentanil-midazolam: a randomized clinical trial].

OBJECTIVE: To assess the effect of stress from surgery on hemodynamics, white cell count, and systemic markers during cholecystectomies performed under 2 intravenous anesthetic techniques. PATIENTS AND METHOD: Randomized clinical trial in patients classified ASA 1 or 2. The patients received 0.15 mg x kg(-1) of midazolam, 1 mg x kg(-1) x h(-1) of ketamine, and 2 microg x kg(-1) of fentanyl (MKF group) or 1 microg x kg(-1) x min of remifentanil and 0.15 mg x kg(-1) of midazolam (RM group). Hemodynamic parameters, white cell counts in circulating blood, and serum levels of cortisol, prolactin, and interleukin-6 were recorded before surgery, after intubation, and at the end of surgery. RESULTS: Thirty-two patients were enrolled. Hemodynamic stability was good in both groups. After intubation, mean (SD) heart rate (75 [14] beats x min(-1)) and systolic (96 [14] mm Hg) and diastolic (60 [7] mm Hg) blood pressures were lower in the RM group than in the MKF group (99 [17] beats x min(-1); 121 [29] mm Hg; and 79 [14] mm Hg, respectively, P<0.01). After surgery whi- te cell (10528 [6480] microL(-1)) and neutrophil (8155 [5657] microL(-1)) counts and cortisol concentration (225 [257] ng x mL(-1)) were significantly lower in the RM patients than in the MKF patients (white cell count, 14,002 [5927] cells x micromL(-1); neutrophil count, 11530 [5657] cells x microL(-1), and 788.8 [146] ng x mL(-1); P<0.01). CONCLUSIONS: The 2 intravenous anesthesia regimens compared differ slightly with regard to their effects on surgical stress. Anesthesia with remifentanil and midazolam contributes to reducing the inflammatory response through modulation of the neurohumoral response to stress.

Adult↗
PubMed1988

Antagonism of midazolam sedation by flumazenil: a placebo-controlled study in patients recovering from intravenous anaesthesia with high doses of midazolam.

Twenty adult surgical patients were anaesthetized with high-dose midazolam and alfentanil by infusion, vecuronium, and intubated and ventilated with 50% N2O in O2. The midazolam and alfentanil infusions were stopped at the end of surgery. Residual neuromuscular blockade and ventilatory depression were antagonized and the patients extubated. In the recovery room, patients were randomly allocated to receive either flumazenil 1 mg of placebo i.v. Before, and until 2 h after injection, patients were asked to perform psychomotor tests. In addition, sedation, comprehension and orientation were scored. The flumazenil (n = 10) and the placebo (n = 10) groups were comparable. Prior to injection all patients were heavily sedated. After flumazenil all were awake within 2-3 min, but fell asleep again 15-60 min later. The improvement in test scores was sustained for a longer time. After placebo, patients awoke in 1-2 h. At 60 and 120 min, test scores in the two groups were similar. Heart rate, blood pressure and respiration rate did not change. No side-effects were observed or reported. It is concluded that flumazenil is an effective and safe antagonist of high dose midazolam, with a rapid onset but a short duration of action.

Adult↗
PubMed1994

Sedation for gastroscopy: a comparison between midazolam and midazolam with nalbuphine.

Forty patients received either midazolam or midazolam with nalbuphine in a double-blind randomised study of sedation for upper gastrointestinal endoscopy. There were less retching, gagging and salivation in the combination group compared to midazolam alone. They were also more cooperative. These resulted in greater ease of insertion of the gastroscope. There was no significant difference in the degree of amnesia in both groups. A significant decrease in oxygen saturation was noted in both groups during the procedure. Monitoring with a pulse oximeter is recommended when sedation is administered during gastroscopy.

Adolescent↗