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Query: UMLS:C0600097 (Sedation)
 1,337 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The Observer's Assessment of Alertness/Sedation (OAA/S) Scale was developed to measure the level of alertness in subjects who are sedated. This scale was tested in 18 subjects in a three-period crossover study to assess its reliability and its criterion, behavioral, and construct validity. After receiving either placebo or a titrated dose of midazolam to produce light or heavy sedation, each subject was administered two sedation scales (OAA/S Scale and a Visual Analogue Scale) and two performances tests (Digit Symbol Substitution Test and Serial Sevens Subtraction). Two raters individually evaluated the subject's level of alertness on each of the two sedation scales. The results obtained on the OAA/S Scale were reliable and valid as measured by high correlations between the two raters and high correlations between the OAA/S Scale and two of the three standard tests used in this study. The OAA/S Scale was sensitive to the level of midazolam administered; all pairwise comparisons were significant (p less than 0.05) for all three treatment levels at both test periods.
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PMID:Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. 228 97

Sixty-three outpatients undergoing breast biopsy procedures with local anesthesia were randomly assigned to receive propofol by intermittent bolus injections (n = 21), a conventional syringe infusion pump (n = 21), or a target-controlled infusion (TCI) device (n = 21) for intraoperative sedation. In the first two groups, an initial intravenous (IV) bolus of propofol (0.3 mg/kg) was administered and an attempt was made to maintain the sedation level at an Observer's Assessment of Alertness/Sedation (OAA/S) score of 3 or 4 with either intermittent bolus injections of propofol (10 mg) or a variable-rate infusion (25-100 micrograms.kg-1.min-1). In the TCI group, the initial target concentration of propofol was set at 2 micrograms/mL and the target concentration was adjusted between 1 and 4 micrograms/mL in an attempt to maintain an OAA/S score of 3 or 4. Recovery was assessed using clinical criteria, visual analog scales (VAS), and the digit-symbol substitution test (DSST). The overall quality of sedation, operating conditions, and clinical recovery profiles were similar in all three treatment groups. The anesthesiologist had to intervene more frequently in the intermittent bolus injection group than in the two infusion groups. We conclude that the use of an infusion technique may allow the anesthesiologist more time for monitoring the patient by decreasing the number of interventions necessary to administer supplemental doses of the sedative medication during the operation. However, the cost of the IV drug delivery system may become an increasingly important factor in the future.
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PMID:Comparison of propofol administration techniques for sedation during monitored anesthesia care. 765 9

Drug development involves the chemical identification and characterization of a compound to determine stability and define the drug's preliminary actions. Preclinical research follows in animals to develop a pharmacokinetic profile to determine dose range, biotransformation, elimination, and toxicology. The 4 phases of clinical research, phase 1 to phase 4, encompass a progressive investigation of healthy subjects, otherwise healthy patients, to patients with a target disease to obtain US Food and Drug Administration (FDA) approval. Clinical studies include open-label noncomparative studies during phases 1 and 2, and double-blind, comparative, and placebo-controlled studies during phases 2 and 3. Approval from the FDA follows the successful evaluation of the drug. After drug marketing, phase 4 clinical trials continue to collect safety and efficacy information. Many drugs that undergo this drug development process succeed in obtaining FDA approval and are marketed for clinical use. There are several circumstances, however, that preclude the successful completion of drug development, FDA approval, and marketing. This study describes a clinical trial of a new benzodiazepine, Ro 48-6791. Ro 48-6791 was being developed as an ultra-short-acting benzodiazepine with clinical effects of shorter duration than midazolam. The purpose of this study was to define a safe dose range for the induction and maintenance of conscious sedation of patients in an outpatient gastroenterology laboratory. Efficacy criteria to be evaluated included time to onset of action, duration of action, and psychomotor fitness upon recovery. Patients were assessed by using the Observer's Assessment of Alertness/Sedation score (OAA/S) and a 5-m heel-toe-line-walk test (HTLW). The patients were divided into 2 groups. Group 1 patients received Ro 48-6791. Group 2 patients were premedicated with meperidine before administration of Ro 48-6791. Ro 48-6791 was titrated over 30 seconds, and patients were observed for 90 seconds before the next dose was given. The OAA/S score, oxygen saturation, and vital signs were charted every minute through induction and every 5 minutes during the procedure. Patients received Ro 48-6791 until they reached on OAA/S score of 3, corresponding to slowed patient response to name calling. Group 1 (Ro 48-6791 alone) required greater induction doses and increased time to induction. Maintenance doses were the same for both groups. The duration of action of Ro 48-6791 as measured by the OAA/S score and HTLW test did not differ between groups. Ro 48-6791 seemed to be a safe and effective agent to achieve conscious sedation in outpatients undergoing short invasive procedures. However, clinical drug development of Ro 48-6791 was stopped because it did not meet the efficacy criteria of an ultra-short-acting benzodiazepine.
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PMID:When the drug trial fails: an approach to clinical drug studies. 1087 42

The bispectral (BIS) index has been used to interpret partial EEG recordings to predict the level of sedation and loss of consciousness in patients undergoing general anesthesia. The author has evaluated BIS technology in determining the level of sedation in patients undergoing outpatient deep sedation. These experiences are outlined in this review article. Initially, the correlation of the BIS index with traditional subjective patient evaluation using the Observer's Assessment of Alertness and Sedation (OAA/S) scale was performed in 25 subjects. In a second study, the recovery profile of 39 patients where the BIS was used to monitor sedation was compared with a control group where the monitor was not used. A strong positive relationship between the BIS and OAA/S readings was found in the initial subjects. From the recovery study, it appears that use of the BIS monitor may help titrate the level of sedation so that less drugs are used to maintain the desired level of sedation. A trend to earlier return of motor function in BIS-monitored patients was also demonstrated. BIS technology offers an objective, ordinal means of assessing the depth of sedation. This can be invaluable in comparing studies of techniques. The BIS index provides additional information to standard monitoring techniques that helps guide the administration of sedative-hypnotic agents. The trend to earlier return of motor function in BIS-monitored patients warrants further investigation.
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PMID:The use of bispectral analysis to monitor outpatient sedation. 1143 60

Nalmefene is a newer, long-acting opioid antagonist. Its use in children for the elective reversal of emergency department procedures has not been investigated. The objective was to evaluate the safety of nalmefene in children. An open-label pediatric clinical trial was performed. The study was conducted at the emergency department of an urban, university-affiliated children's hospital and consisted of children aged 6 months to 12 years who required procedural sedation where an opioid agent was administered. Patients were excluded if there was altered mental status, history of head trauma, history of opioid allergy, or the anticipated need for opioid agents for pain relief after the procedure. At the completion of the procedure, nalmefene was administered in a dose of 0.25 microg/kg increments (max 10 microg) until sedation was resolved, or to a maximum of 1.0 microg/kg (max 40 microg). Serial ECGs, vital signs, and oxygen saturation were recorded. Sedation was assessed using the Clinical Global Impression Scale (CGIS) at baseline, 2, 4, 6, 8, and 10 minutes after the initial nalmefene dose. The observer's assessment of alertness and sedation (OAA/S) was measured at baseline, 10, 30, 60, 90, and 120 minutes after the first dose of nalmefene. Episodes of resedation were recorded. All patients received follow-up by telephone at 4 and 24 hours after the initial dose of nalmefene to identify any potential late adverse effects. Over the study interval 15 patients were enrolled. Mean age was 59.1 +/- 41.5 months. Procedures involved fracture reduction (n=8), laceration repair (n = 4), abscess drainage (n = 2), and arthrocentesis (n = 1). All patients received IV fentanyl and midazolam. The mean dosage of fentanyl and midazolam was 3.21 +/- 1.03 microg/kg and 0.07 +/- 0.03 mg/kg, respectively. The mean dose of nalmefene at the time of complete response (CGIS = 1 or 2) was 0.55 +/- 0.29 microg/kg. The median number of nalmefene doses was 2. All but one patient (93%) had a complete response based on CGIS at 10 minutes after the initial dose of nalmefene was given. Nalmefene resulted in a significant improvement in CGIS (1.60 +/- 0.82 v 3.26 +/- 0.88, P =.001) and OAA/S (median score 5 v 4) when compared at baseline with 10 minutes after the initial dose of nalmefene. Nalmefene also resulted in increased diastolic blood pressure (62.6 +/- 10.5 v 55.8 +/- 10.7, P =.04) as well as improved oxygen saturation when compared at 120 minutes to baseline (99.5 +/- 0.74% v 98.5 +/- 0.4%, P =.03). There were no significant changes in pulse, systolic blood pressure, respiratory rate, and ECG. None of the patients became resedated after nalmefene was given. One patient developed nausea and vomiting within the first 2 hours after nalmefene; this resolved without intervention before discharge. No adverse events occurred in any of the patients at 4 and 24 hours postadministration. The results of this study showed that nalmefene is effective and safe for reversal of procedural sedation by opioids in children.
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PMID:Nalmefene for elective reversal of procedural sedation in children. 1169 98

Investigators in the field of depth of anaesthesia monitoring sometimes measure the auditory evoked potential (AEP) and the Bispectral Index (BIS) concurrently. However, the auditory stimuli required to generate an AEP may increase the level of consciousness, and cause an increase in the BIS. They may also alter the BIS by producing phase-locked harmonics in the surface electroencephalogram. The aim of this study was to determine if AEP stimuli have clinically significant effects on levels of consciousness and BIS values during sedation and general anaesthesia. Ten healthy adult patients were studied by measuring and recording the BIS for 6 epochs of 5 min each. The first 3 epochs took place during steady-state sedation, during which time the Observer's Assessment of Awareness/Sedation (OAA/S) score was also measured. The second 3 epochs took place during steady-state anaesthesia. During alternate epochs, patients were subjected to the auditory stimuli generated by an AEP system. The auditory stimuli were not associated with a change in BIS values (during sedation and anaesthesia) or OAA/S scores (sedation).
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PMID:Effects of the auditory stimuli of an auditory evoked potential system on levels of consciousness, and on the bispectral index. 1187 32

Cancer patients often report complaints of cognitive impairment and sedation. It is not well known if subjective complaints reflect objective assessments of cognitive function (CF) and sedation. We obtained self-reports of sedation and CF from 29 patients admitted to a palliative care unit and receiving morphine treatment. Sedation was reported on a verbal rating scale (VRS) and CF was reported using the EORTC QLQ-C30 health-related quality-of-life questionnaire CF scale. The self-reports were compared with objective assessments of sedation and CF by applying the Observer's Assessment of Alertness/Sedation (OAA/S) scale and Mini Mental State Examination (MMS), respectively. The assessments were repeated for seven patients who were readmitted to the palliative care unit. The patient self-reports of memory, concentration and sedation were dichotomized into noncomplainers and complainers. The percentages of complainers were 54%, 46% and 37% for memory, concentration and sedation, respectively. Patients who complained from difficulties with concentration or memory did not score differently from noncomplainers on objective assessments of CF (MMS score), but had a significantly higher level of fatigue. Patients complaining from sedation did not score differently from noncomplainers on objective assessments of sedation (OAA/S score). We observed no significant correlations between EORTC QLQ-C30 CF scale scores and MMS scores, or between VRS sedation scores and OAA/S scores. The study demonstrates a lack of relationship between patient self-reports and objective methods for assessing sedation and cognitive failure. This finding illustrates the importance of differentiating between observations and patient self-reports. The results also question the validity of patient self-reports for measurements of cognitive failure and sedation.
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PMID:Self-reports are not related to objective assessments of cognitive function and sedation in patients with cancer pain admitted to a palliative care unit. 1246 99

This study was performed to investigate the quality of different intravenous sedation techniques, and the correlation between the Bispectral Index (BIS) values and the Observer's Assessment of Alertness/Sedation (OAA/S) scores. Eighty patients undergoing sinonasal surgery were randomly assigned to one of four groups. Group MF received midazolam and fentanyl, group PF received propofol and fentanyl, group MR received midazolam and remifentanil, and group PR received propofol and remifentanil. Heart rate and mean arterial pressure values were not different among the groups. SpO2 decreased only after intravenous medication in groups MF and MR (P < 0.017). Emesis was less common with propofol. A positive relationship existed between the BIS values and OAA/S scores during the operation in all groups and the strongest correlation was observed in group PR (r = 0.565 and P < 0.001). In conclusion, these four intravenous sedation techniques did not change mean arterial pressure, heart rate or SpO2 clinically and produced a similar level of light sedation. The BIS was useful for monitoring of sedation during sinonasal surgery under local anaesthesia with intravenous sedation.
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PMID:A comparison of four intravenous sedation techniques and Bispectral Index monitoring in sinonasal surgery. 1271 79

: A randomized, double-masked, placebo-controlled study was designed to compare dexmedetomidine as a primary sedative agent with a commonly used drug combination in patients undergoing awake carotid endarterectomy (CEA). Sixty-six patients undergoing CEA (ASA II-IV) were randomly assigned to receive either dexmedetomidine (total dose of 97.5 +/- 54.7 mcg) or normal saline (control). Supplemental doses of midazolam, fentanyl, and/or propofol were administered as deemed necessary by the anesthesiologist. An observer blinded to the study drug assessed sedation level (Observer's Assessment of Alertness-Sedation [OAA/S] scale). The primary outcomes were defined as the number of patients with an OAA/S score of 4 intraoperatively and an OAA/S score of 5 postoperatively. The authors also compared cardiorespiratory parameters, intra- and postoperative side effects, and complications. Chi-square tests were used to analyze the primary endpoints. All secondary parameters were analyzed using the Wilcoxon rank sum test. Three patients in the dexmedetomidine group (10%) had an OAA/S score of 4 at all four time points assessed intraoperatively, while no patient in the control group had a score of 4 at all the time points considered. Thirteen patients in the dexmedetomidine group had a score of 4 at three or more time points (42%) compared with six patients (19%) in the control group. Four patients in the control group (13%) and one patient in the dexmedetomidine group (3%) did not achieve a score of 4 at any of the four critical intraoperative time points (chi for association = 9.9, P < 0.05; chi for a trend = 8.6, P < 0.004, with the trend favoring dexmedetomidine). More patients in the control group required treatment with metoprolol (26% vs. 6%, P = 0.04) and labetalol (48% vs/ 6%, P < 0.01). Plasma levels of norepinephrine were significantly lower in the dexmedetomidine group during and after surgery compared with the control group. Six patients (19%) in the dexmedetomidine group required intra-arterial shunts, while only two patients (6%) required shunts in the control group (P = 0.16). These data show that the use of dexmedetomidine in patients undergoing awake CEA resulted in fewer fluctuations from the desired sedation level. Patients receiving dexmedetomidine required less antihypertensive therapy compared with the midazolam/fentanyl/propofol combination. The effect of dexmedetomidine on cerebrovascular circulation in the study population needs further investigation.
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PMID:Dexmedetomidine for awake carotid endarterectomy: efficacy, hemodynamic profile, and side effects. 1555 42

This single-blind controlled clinical study characterized the effects of 30-70% nitrous oxide (N2O) and 0.2-0.8% sevoflurane conscious sedation on quantitative electroencephalographic (EEG) readings of 22 healthy dental students as measured by the bispectral index (BIS). The study verified the 2 previously published BIS/N2O investigations showing no correlation between N2O dosage up to 70% and BIS. Observer's Assessment of Alertness and Sedation scores (OAA/S), however, correlated well with increasing doses of N2O from approximately 35 to 70%. A near linear dose-response relationship was established between OAA/S and end tidal (ET) sevoflurane concentrations of 0.4-0.7%. Only at the highest level of end tidal sevoflurane recorded, 0.7%, was statistically significant BIS depression seen. Subjects evaluated the acceptability of the sedative effect of the 2 gases, showing a slight preference for N2O. Comparable partial anterograde amnesia and sedation (OAA/S) were produced by both agents in administered concentrations of 40-70% N2O and 0.6-0.8% sevoflurane. Female subjects exhibited better memory and significantly less amnesia than males. No statistically significant changes occurred in any of the monitored vital signs. EMG readings demonstrated a statistically significant difference from control values only at the highest, 0.7%, ET concentration of sevoflurane. BIS does not appear useful for evaluating the level of nitrous oxide sedation in the dental setting but may have some value in assessing depth of sedation at deeper levels of sevoflurane sedation.
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PMID:Bispectral EEG index monitoring of high-dose nitrous oxide and low-dose sevoflurane sedation. 1538 93


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