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PubMed1987

Randomized clinical investigation of Ro 15-1788, a benzodiazepine antagonist, in reversing the central effects of flunitrazepam.

In a double-blind, randomized study the efficacy of Ro 15-1788 as a benzodiazepine antagonist was evaluated in patients anaesthetized with flunitrazepam. The effects were compared with a comparable group of patients who did not receive the antagonist. Ro 15-1788 significantly reversed the sedative and hypnotic effects of flunitrazepam and reduced the degree of anterograde amnesia. No side-effects were attributable to the drug.

Adjuvants, Anesthesia↗
PubMed1979

[The influence of sedation with diazepam and flunitrazepam during regional anaesthesia upon postoperative pulmonary performance (author's transl)].

In 32 patients between 53 and 86 years of age, undergoing transurethral prostatectomy, the influence of intraoperative sedation with Diazepam (5-10 mg) and Flunitrazepam (0,4-0,8 mg) on postoperative forced vital capacity, forced exspiratory volume (1 sec.) and peakflow, were measured, compared to placebo. We could not find a depression of these ventilatory parameters, in the three groups except peak-flow after sedation with Flunitrazepam in the evening after operation (p less than or equal to 0,05). We conclude that sedation during regional anesthesia does not impair the most important advantage of local anesthesia, the minor effect on ventilation, compared with general anesthesia.

Anesthesia, Conduction↗
PubMed1988

The effect of flunitrazepam on acoustic reflex--a methodological pilot study.

Four healthy volunteers took part in this study in four sessions at one week intervals minimum. Three intravenous dose levels of flunitrazepam as well as placebo (saline) were investigated. The sessions were randomized and the study was double blind. The results show that a significant correlation exists between the serum concentrations of flunitrazepam and acoustic reflex amplitude, latency, Maddox wing readings and subjective sedation. Critical flicker fusion frequency test was insensitive in this respect. We conclude that acoustic reflex may be a new method for determination of benzodiazepine effects in man.

Double-Blind Method↗
PubMed1986

Plasma concentrations of flunitrazepam (Rohypnol) following oral and sublingual administration.

Flunitrazepam (Rohypnol) 2.0 mg was given as a single dose by the oral or sublingual route to ten volunteers using a cross-over design. Plasma concentrations of the drug were measured by gas-liquid chromatography for up to 6 hours after administration. The highest mean concentration occurred 45 min after administration irrespective of route. No significant differences were found between the two treatments at any time. Since the sublingual route compares favorably with other routes of administration, these findings suggest that sublingual flunitrazepam is valuable for premedication.

Administration, Oral↗
PubMed1986

Regional distribution of flunitrazepam binding constants: visualizing Kd and Bmax by digital image analysis.

We demonstrate direct visualization of benzodiazepine binding parameters collected in a 3H-flunitrazepam saturation study. In this way the relationship between anatomy and specific binding, Kd and Bmax, can be appreciated. These experiments have resulted in image representations of specific flunitrazepam binding, Kd and Bmax. The images retain the anatomic localization inherent in the original autoradiogram and hence make these parameters amenable to visual survey. Binding constants were consistent with data presented elsewhere in the literature. The image of Bmax showed regional heterogeneity. Kd, on the other hand, was relatively homogeneous. These results demonstrate a means by which autoradiographic binding experiments can be extended to saturation studies without significant loss of data.

Animals↗
PubMed1986

[Plasma concentration and amnesia following lormetazepam and flunitrazepam in i.v. premedication].

The correlation between serum levels and degree of amnesia following 0.03 mg/kg lormetazepam or 0.02 mg/kg flunitrazepam was analysed in a prospective randomised single-blind study evaluating 20 patients with ASA classification I in each group. Blood specimens were drawn and amnesia tests performed 20, 40 and 60 min. after drug administration. The plasma level of lormetazepam was 1.8 to 2.0 times higher than that of flunitrazepam; however, the difference of lormetazepam concentrations was considerably large between the investigated individuals. There was no difference in the degree of amnesia, but also no correlation with plasma levels was measured. A serum level breakpoint for the occurrence of amnesia could not be defined.

Adolescent↗
PubMed1979

[Influence of narcotic analgesics, droperidol, diazepam, and flunitrazepam on the smooth muscles of small arteries (author's transl)].

In isolated segments of the rat tail artery, the influence of narcotic analgesics, their antagonists, droperidol, diazepam, and flunitrazepam on the vascular smooth muscle was investigated. The wall of this vessel consists of about 75 per cent smooth muscle fibres. For all agents studied, pressure-diameter relations were determined before and after a virtually maximum constriction which was induced with noradrenaline. The results were compared with those obtained under control conditions, i.e. prior to the addition of the drugs to the bath solution. Tested in pure Tyrode's solution, none of the agents produced a noticeable constriction or relaxation. Among the analgesics and their antagonists, morphine was the most potent in inhibiting the noradrenaline-induced constriction of the vessel (mean increase in diameter 15%). Pentazocine and levallorphan were less effective (mean increase 8%), and the administration of pethidine and naloxone was followed by even less relaxation, resulting in mean diameter increases of 4%. Piritramide and fentanyl did not show any effect. Depending on the pressure level, droperidol caused the diameter to increase 2 to 10%. Flunitrazepam brought about a marked relaxation (mean increase in diameter 15%), diazepam, however, did not influence the vessel segments. The results obtained show that the haemodynamic effects of the drugs used in this study, in particular those on the peripheral resistance, may, at least partially, be due to their direct influences on the vascular smooth muscle. The real pharmacologic mechanisms by which these effects are initiated, in most cases still remain to be investigated.

Analgesics, Opioid↗
PubMedDate not supplied

Sedative effects and cardiorespiratory influences of intravenous flunitrazepam premedication.

Sedative effects and the influence on cardiorespiratory functions of flunitrazepam, 0.015 mg/kg intravenously, were studied in 13 healthy adult volunteers. Immediately after administration, 12 of the 13 subjects responded when their names were called, while one subject required gentle patting on the shoulder to evoke a response. The scores of EEG and electro-oculogram were decreased. Cardiorespiratory changes were mild and not significant clinically. Anterograde amnesia was remarkable. Equilibrium functions were normal at 180 min postdose. Only one subject complained of pain at injection. It was concluded that intravenous injection of 0.015 mg/kg flunitrazepam was an optimal dose for sedation in healthy adults.

Adult↗
PubMed1980

[The effect on breathing of flunitrazepam and benzoctamine as adjuvants in spinal anesthesia in broncho-pulmonary risk patients].

The influence of intravenous Flunitrazepam (0.4-0.8 mg), Benzoctamine (10-20 mg) and Placebo (NaCl 0.9%) on pO2, pCO2, forced vital capacity, forced expiratory volume and peak flow were investigated in patients with reduced lung function undergoing orthopaedic surgery under spinal anaesthesia. Both drugs depress respiration: Flunitrazepam immediately, Benzoctamine about 15 min after administration. Both drugs reduce lung function in the postoperative period. They should be administered under careful observation of patients' respiration, administration of oxygen and only in special cases where sedation is necessary to reduce psychological stress. The advantage of regional anaesthesia in patients with high risk of postoperative pulmonary failure seems worth retaining compared to general anaesthesia.

Anesthesia, Spinal↗
PubMed1980

[The effects of flunitrazepam and benzoctamine on the blood gases during translumbar aortography in spinal analgesia (author's transl)].

In thirty patients the influence of intravenous Flunitrazepam (0.4-0.8 mg) and Benzoctamine (10-20 mg) on blood gases during short acting diagnostic procedures in spinal anaesthesia in prone position was investigated. The changes of paO2 and PaCO2 were neglectible after Benzoctamin and a control group up to 10 minutes after injection. After Flunitrazepam there was a significant reduction of paO2 and rise of paCO2. The results are discussed.

Anesthesia, Spinal↗
PubMed1981

[Psychosomatic effects of intramuscular premedication wtih flunitrazepam, innovar and a placebo in combination with atropine (author's transl)].

A double-blind technique was used for studying the psychic and somatic effects of premedication with flunitrazepam, innovar and a placebo in 116 patients. Innovar and the placebo produced the same results. Flunitrazepam reduced anxiety and apprehension and had a significantly higher amnesic effect. Premedication with Innovar increased not only a feeling of fatigue and heaviness but also anxiety and tension in the patients. When assessing the psychic effects of premedication attention must be paid to the subjective impressions on the part of the patient.

Adult↗
PubMed1980

[Ultrastructure of the retina in flunitrazepam anesthesia].

Ultrastructure of the retina under experimental flunitrazepam anaesthesia of 1 hour duration was studied. Alterations of neurons and glial cells were not revealed neither after cessation of anaesthesia, nor following 24 or 48 hours after it. These findings seem to indicate that flunitrazepam has no effect on the metabolism of the retina, thus its application in the ophtalmology is free of side effects.

Anesthesia, Intravenous↗
PubMed1981

[Clinical pharmacokinetics of flunitrazepam (Nacrozep) in intensive care patient (preliminary results)].

A protocol of repeated I. V. injections of flunitrazepam was constructed by mathematical simulation on the basis of pharmacokinetic data obtained from single intravenous injections given to healthy subjects. This protocol would given serum blood levels equal to 15 ng . ml-1, rapidly and compatible with long term artificial ventilation, thanks to the pharmacological action of flunitrazepam. Four patients in the ICU benefited from this protocol. The levels desired were not reached but in two cases out of four it was possible to continue artificial ventilation without the addition of any other drug. Furthermore it was possible to show that the three compartment model developed from healthy subjects remains valid in pathological circumstances. A second protocol based on pharmacokinetic data from four patients should allow us to obtain the objective aimed at.

Adult↗
PubMed1982

Highly specific and sensitive method for the determination of flunitrazepam in plasma by electron capture gas-liquid chromatography.

A sensitive and highly specific electron capture gas-liquid chromatographic method was developed for the determination of flunitrazepam in human plasma. The method involves selective extraction of the drug into hexane from plasma at pH 9 followed by back-extraction into 2 N sulfuric acid for clean-up procedure, and re-extraction by 20% toluene-hexane at pH 2. The sensitivity limit of the method is 0.5 ng/ml of plasma. Its specificity was tested for about 45 drugs frequently administered as co-medication in hospitalized patients, including other benzodiazepines. The method proves very suitable for investigating the clinical pharmacokinetics of flunitrazepam as well as for monitoring therapeutic plasma levels and in forensic situations following over-dosage, and was successfully applied within a clinical pharmacokinetic study in an intensive care unit.

Anti-Anxiety Agents↗
PubMed1982

Kinetics of [3H]flunitrazepam binding to membrane-bound benzodiazepine receptors.

The kinetics of [3H]flunitrazepam binding to synaptosomal (P2) membranes from rat cerebral cortex was studied. The pseudo-first order association at 0 degrees was curvilinear and the association rate was increased with increasing concentrations of ligand. The association curve was resolved best as two linear exponentials, representing a fast and a slow component. The percentage of each association component varied with the ligand concentration. Association was slightly decreased in the presence of gamma-aminobutyric acid. Dissociation at 0 degrees, whether equilibrium binding had occurred at 0 degrees or 37 degrees, was also biphasic. The dissociation of the complexes was more rapid at higher concentrations of ligand. Dissociation was slower in the presence of gamma-aminobutyric acid, and this effect was more pronounced at higher concentrations of ligand. Prolonged preincubation at 37 degrees either in the presence or in the absence of [3H]flunitrazepam also decreased the dissociation rate. Dissociation was faster before equilibrium than after equilibrium had been reached. These results are discussed in terms of one homogeneous type of benzodiazepine receptor with two interconvertible conformations.

Animals↗
PubMed1983

[11C-Ro15-1788 and 11C-flunitrazepam, two coordinates for the study by positron emission tomography of benzodiazepine binding sites].

In vivo binding of a benzodiazepine (flunitrazepam-C11) and a benzodiazepine antagonist (Ro 15-1788-C11) were studied with positron emission tomography. Advantages and disadvantages of each drug for studying specific in vivo binding sites are presented. The results obtained indicate that Ro 15-1788-C11 is a better in vivo radiocoordinat than flunitrazepam-C11.

Animals↗
PubMed1984

[Toxic genetic effects of flunitrazepam].

The mutagenic activity of Flunitrazepam, the active ingredient of the drug Rohypnol, has been investigated by using the Salmonella/microsome mutagenicity test. A dose-related mutagenic effect was observed on Salmonella typhimurium strain TA 100 either in the absence or in the presence of a rat liver microsomal fraction (S9) as in vitro metabolic activation system. By adopting a modification of the Salmonella test, the mutagenicity of urines from rats or patients treated with the drug was evaluated. In these cases mutagenic activity was detected toward the Salmonella strains TA 98 and TA 100 both in presence and in absence of the metabolic activation system. The data indicate that Flunitrazepam and/or its urinary metabolites can induce both base-pair substitutions or frame-shift point mutations.

Animals↗
PubMedDate not supplied

Flunitrazepam, a new benzodiazepine compound in general anaesthesia. Clinical and statistical considerations on the first thousand cases.

Flunitrazepam, a derivative of benzodiazepine was used for induction and maintenance of anaesthesia in 933 patients. The induction dose was from 1,786 to 2,053 mg. The total dose of 2-2.66 mg was sufficient for maintenance of hypnosis for about 2 hours. The undesirable side effects were very rare. The average time of hypnosis after a single dose of flunitrazepam was 50.1 sec. The sedative action of the drug lasted for some time after regaining of consciousness. In most patients there was no need for administration of analgetics during first 24 hours after the operation. The authors believe that surgical anaesthesia will greatly benefit from this drug.

Adolescent↗