EVALUATION OF MIDAZOLAM AND DIAZEPAM FOR PRE-OPERATIVE SEDATION.
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ABSTRACT:
SUBMITTER: Suri Y
PROVIDER: S-EPMC5532121 | biostudies-other | 2000 Oct
REPOSITORIES: biostudies-other
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Project description: Not available
| S-EPMC6517181 | biostudies-literature
Project description:Dexmedetomidine was shown in two European randomized double-blind double-dummy trials (PRODEX and MIDEX) to be non-inferior to propofol and midazolam in maintaining target sedation levels in mechanically ventilated intensive care unit (ICU) patients. Additionally, dexmedetomidine shortened the time to extubation versus both standard sedatives, suggesting that it may reduce ICU resource needs and thus lower ICU costs. Considering resource utilization data from these two trials, we performed a secondary, cost-minimization analysis assessing the economics of dexmedetomidine versus standard care sedation.The total ICU costs associated with each study sedative were calculated on the basis of total study sedative consumption and the number of days patients remained intubated, required non-invasive ventilation, or required ICU care without mechanical ventilation. The daily unit costs for these three consecutive ICU periods were set to decline toward discharge, reflecting the observed reduction in mean daily Therapeutic Intervention Scoring System (TISS) points between the periods. A number of additional sensitivity analyses were performed, including one in which the total ICU costs were based on the cumulative sum of daily TISS points over the ICU period, and two further scenarios, with declining direct variable daily costs only.Based on pooled data from both trials, sedation with dexmedetomidine resulted in lower total ICU costs than using the standard sedatives, with a difference of €2,656 in the median (interquartile range) total ICU costs-€11,864 (€7,070 to €23,457) versus €14,520 (€7,871 to €26,254)-and €1,649 in the mean total ICU costs. The median (mean) total ICU costs with dexmedetomidine compared with those of propofol or midazolam were €1,292 (€747) and €3,573 (€2,536) lower, respectively. The result was robust, indicating lower costs with dexmedetomidine in all sensitivity analyses, including those in which only direct variable ICU costs were considered. The likelihood of dexmedetomidine resulting in lower total ICU costs compared with pooled standard care was 91.0% (72.4% versus propofol and 98.0% versus midazolam).From an economic point of view, dexmedetomidine appears to be a preferable option compared with standard sedatives for providing light to moderate ICU sedation exceeding 24 hours. The savings potential results primarily from shorter time to extubation.ClinicalTrials.gov NCT00479661 (PRODEX), NCT00481312 (MIDEX).
| S-EPMC4391080 | biostudies-literature
Project description:To better understand 'when' and 'where' wideband electrophysiological signals are altered by sedation.We generated animation movies showing electrocorticography (ECoG) amplitudes at eight spectral frequency bands across 1.0-116 Hz, every 0.1s, on three-dimensional surface images of 10 children who underwent epilepsy surgery. We measured the onset, intensity, and variance of each band amplitude change at given nonepileptic regions separately from those at affected regions. We also determined the presence of differential ECoG changes depending on the brain anatomy.Within 20s following injection of midazolam, beta (16-31.5 Hz) and sigma (12-15.5 Hz) activities began to be multifocally augmented with increased variance in amplitude at each site. Beta-sigma augmentation was most prominent within the association neocortex. Augmentation of low-delta activity (1.0-1.5 Hz) was relatively modest and confined to the somatosensory-motor region. Conversely, injection of midazolam induced attenuation of theta (4.0-7.5 Hz) and high-gamma (64-116 Hz) activities.Our observations support the notion that augmentation beta-sigma and delta activities reflects cortical deactivation or inactivation, whereas theta and high-gamma activities contribute to maintenance of consciousness. The effects of midazolam on the dynamics of cortical oscillations differed across regions.Sedation, at least partially, reflects a multi-local phenomenon at the cortical level rather than global brain alteration homogeneously driven by the common central control structure.
| S-EPMC4747792 | biostudies-literature
Project description:Transesophageal echocardiography (TEE), being a displeasing intervention, usually entails sedation. We aimed to compare the effects of hypnosis and midazolam for sedation in TEE.A prospective single-blinded study conducted on patients scheduled for TEE between April 2011 and July 2011 at a university in Istanbul, Turkey.A total of 41 patients underwent sedation using midazolam and 45 patients underwent hypnosis. Patients were given the State-Trait Anxiety Inventory (STAI) test for anxiety and continuous performance test (CPT) for alertness before and after the procedure. The difficulty of probing and the overall procedure rated by the cardiologist and satisfaction scores of the patients were also documented.Anxiety was found to be less and attention more in the hypnosis group, as revealed by STAI and CPT test scores (P < .05 and P < .001, respectively).Hypnosis proved to be associated with positive therapeutic outcomes for TEE with regard to alleviation of anxiety and maintenance of vigilance, thus providing more satisfaction compared to sedation with midazolam.
| S-EPMC6152553 | biostudies-literature
Project description:A randomized double-blinded controlled trial was performed to explore the association between pre-operative anxiety and intra-operative butorphanol requirement to evaluate the precise sedative requirement and to confirm the sedative effect of butorphanol in patients receiving lower-limb orthopedic surgery. The Amsterdam pre-operative anxiety and information scale and the Ramsay sedation score (RSS) were used to assess the patients' pre-operative anxiety score and sedation state during surgery. Patients were divided into two groups according to their pre-operative anxiety score prior to administration of pre-medication. Patients in each group were randomly divided into a butorphanol group and a 0.9% saline group. A total of 142 patients were enrolled and 131 patients were analyzed. The sedation scores of patients with high pre-operative anxiety in the 0.9% saline group were lower than those in the butorphanol group at each time-point after infusion. An increased pre-operative anxiety score predicted an increased duration to reach an RSS of 4 for an acceptable level of sedation (r2=0.887, P<0.0001). In conclusion, butorphanol had a good sedative effect on patients with pre-operative anxiety. The following formula was proposed: Precise dose of butorphanol (µg/kg)=15.26 + (0.14× pre-operative anxiety score), which may provide an improvement for patients exhibiting a high level of pre-operative anxiety. The trial was registered prior to patient enrollment at clinicaltrials.gov on 20.01.2018 (trial registration no. NCT03429179).
| S-EPMC6781787 | biostudies-literature
Project description:PURPOSE:The optimal sedative regime that provides the greatest comfort and the lowest risk for procedural sedation in young children remains to be determined. The aim of this randomized, blinded, controlled, parallel-design trial was to evaluate the efficacy of intranasal ketamine and midazolam as the main component of the behavioral guidance approach for preschoolers during dental treatment. MATERIALS AND METHODS:Children under seven years of age, with caries and non-cooperative behavior, were randomized into three groups: (KMIN) intranasal ketamine and midazolam; (KMO) oral ketamine and midazolam; or (MO) oral midazolam. The dental sedation appointments were videotaped, and the videos were analyzed using the Ohio State University Behavioral Rating Scale (OSUBRS) to determine the success of the sedation in each group. Intra- and postoperative adverse events were recorded. Data analysis involved descriptive statistics and non-parametric tests (P < 0.05, IBM SPSS). RESULTS:Participants were 84 children (28 per group; 43 boys), with a mean age of 3.1 years (SD 1.2). Children's baseline and the dental sedation session characteristics were balanced among groups. The success of the treatment as assessed by the dichotomous variable 'quiet behavior for at least 60% of the session length' was: KMIN 50.0% (n = 14; OR 2.10, 95% CI 0.71 to 6.30), KMO 46.4% (n = 13; OR 1.80, 95% CI 0.62 to 5.40), MO 32.1% (n = 9) (P = 0.360). Adverse events were minor, occurred in 37 of 84 children (44.0%), and did not differ among groups (P = 0.462). CONCLUSION:All three regimens provided moderate dental sedation with minor adverse events, with marked variability in the behavior of children during dental treatment. The potential benefit of the ketamine-midazolam combination should be further investigated in studies with larger samples. TRIAL REGISTRATION:ClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."
| S-EPMC6411109 | biostudies-literature
Project description:ObjectivesTo systematically review the literature comparing the efficacy and safety of dexmedetomidine and midazolam when used for procedural sedation.Materials and methodsWe searched MEDLINE, EMBASE and COCHRANE for clinical trials comparing dexmedetomidine and midazolam for procedural sedation up to June 20, 2016. Inclusion criteria: clinical trial, human subjects, adult subjects (?18 years), article written in English, German, French or Dutch, use of study medication for conscious sedation and at least one group receiving dexmedetomidine and one group receiving midazolam. Exclusion criteria: patients in intensive care, pediatric subjects and per protocol use of additional sedative medication other than rescue medication. Outcome measures for efficacy comparison were patient and clinician satisfaction scores and pain scores; outcome measures for safety comparison were hypotension, hypoxia, and circulatory and respiratory complications.ResultsWe identified 89 papers, of which 12 satisfied the inclusion and exclusion criteria; 883 patients were included in these studies. Dexmedetomidine was associated with higher patient and operator satisfaction than midazolam. Patients receiving dexmedetomidine experienced less pain and had lower analgesic requirements. Respiratory and hemodynamic safety were similar.ConclusionsDexmedetomidine is a promising alternative to midazolam for use in procedural sedation. Dexmedetomidine provides more comfort during the procedure for the patient and clinician. If carefully titrated, the safety profiles are similar.
| S-EPMC5249234 | biostudies-literature
Project description:Purpose of Review:Pre-operative endocrine therapy can be used to down-stage large or locally advanced breast cancers in ER+ disease. In the last four decades, it has evolved from a treatment perceived as an alternative to surgery for those too unfit to undergo surgery or chemotherapy, to the present day where it is a valuable and valid option in the treatment of postmenopausal women with ER-rich (Allred score 7-8, or > 50% staining for ER) breast cancer. Recent Findings:Emerging data from the metastatic setting is translating into neoadjuvant trials, utilising dual endocrine targeting or combinations of endocrine agents and other targeted drugs, including those acting against components of the PI3K pathway and the cell cycle. The routine use of peri-operative endocrine therapy in all ER+ tumours may help to yield important long-term prognostic information, and guide adjuvant endocrine therapy. Summary:Pre-operative endocrine therapy is an exciting and evolving area with emerging new approaches. In this review, established evidence and emerging data on its applications are discussed.
| S-EPMC5694502 | biostudies-literature
Project description:Objectives/Aims:There has been no dentistry-specific published data supporting the use of monitoring with capnography for dental sedation. Our aim was to determine if adding capnography to standard monitoring during conscious sedation with midazolam would decrease the incidence of hypoxaemia. Materials and Methods:A randomised controlled trial was conducted in which all patients (ASA I and II) received standard monitoring and capnography, but were randomised to whether staff could view the capnography (intervention) or were blinded to it (control). The primary outcome was the incidence of hypoxaemia (SpO2?94%). Results:We enrolled 190 patients, mean age 31 years (range, 14-62 years). There were 93 patients in the capnography group and 97 in the control group. The mean cumulative dose of midazolam titrated was 6.94?mg (s.d., 2.31; range, 3-20?mg). Six (3%) patients, three in each group, required temporary supplemental oxygen. There was no statistically significant difference between the capnography and control groups for the incidence of hypoxaemia: 34.4 vs 39.2% (P=0.4962, OR=0.81, 95% CI: 0.45-1.47). Conclusions:We were unable to confirm an additive role for capnography to prevent hypoxaemia during conscious sedation with midazolam for patients not routinely administered supplemental oxygen.
| S-EPMC5842831 | biostudies-literature
Project description:An audit of 143 surgical admissions showed that only 30% of general surgery and urology patients have complete medication charts on the day of surgery prior to going to theatre, compared to 94% of orthopaedic patients. This was despite having been seen previously in the pre-operative assessment clinic (POAC). These patients went to the wards post-operatively, where many then missed doses of their life-sustaining medications. Orthopaedic patients see a prescribing pharmacist in POAC who undertakes medicines reconciliation; this is performed by junior doctors for surgical patients. We designed three interventions to improve drug chart completion by junior doctors, and gathered prospective data for 22 weeks in the POAC. We also recorded attendance of junior doctors in the POAC and reasons for absence. Daily and weekly percentages of drug chart completion were plotted on a run chart. The baseline completion rate was 43%. This rose to 45% after the first and second interventions, and 51% after the third intervention. However, the completion rate remained markedly below our target of 94%. Junior doctors attended only 44% of POACs. They reported being "too busy to attend" 41% of the time, and could not be contacted on 11% of occasions. Junior doctors reported that they were unable to attend to both unwell inpatients and the POAC, the latter seeming less of a priority. This was despite a rota allocating doctors to attend POAC sessions free from clinical or teaching commitments. We were unable to increase the rate of drug chart completion with the resources available. We therefore recommend the employment of prescribing pharmacists in the POAC for general surgery and urology patients.
| S-EPMC4949617 | biostudies-literature