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      Pharmacodynamic Estimate of Propofol-Induced Sedation and Airway Obstruction Effects in Obstructive Sleep Apnea-Hypopnea Syndrome

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          Abstract

          Purpose

          Sedatives must be carefully titrated for patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) as oversedation may lead to disastrous respiratory outcomes. This study aimed to investigate the relations between the effect-site concentration ( Ce) of propofol and sedation and airway obstruction levels in patients with OSAHS.

          Materials and Methods

          In 25 patients with OSAHS, sedation was induced by 2% propofol using target-controlled infusion. Sedation and airway obstruction levels were assessed using the Observer's Assessment of Alertness/Sedation Scale and a four-category scale, respectively. The relationships between propofol Ce and sedation and airway obstruction were evaluated using a sigmoid Emax model. Pharmacodynamic modeling incorporating covariates was performed using the Nonlinear Mixed Effects Modeling VII software.

          Results

          Increased propofol Ce correlated with the depth of sedation and the severity of airway obstruction. Predicted Ce 50(m) ( Ce associated with 50% probability of an effect≥m) for sedation scores (m≥2, 3, 4, and 5) and airway-obstruction scores (m≥2, 3, and 4) were 1.61, 1.78, 1.91, and 2.17 µg/mL and 1.53, 1.64, and 2.09 µg/mL, respectively. Including the apnea-hypopnea index (AHI) as a covariate in the analysis of Ce 50(4) for airway obstruction significantly improved the performance of the basic model ( p<0.05).

          Conclusion

          The probability of each sedation and airway obstruction score was properly described using a sigmoid Emax model with a narrow therapeutic range of propofol Ce in OSAHS patients. Patients with high AHI values need close monitoring to ensure that airway patency is maintained during propofol sedation.

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          Most cited references21

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          Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam.

          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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            Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable Monitoring Task Force of the American Academy of Sleep Medicine.

            Based on a review of literature and consensus, the Portable Monitoring Task Force of the American Academy of Sleep Medicine (AASM) makes the following recommendations: unattended portable monitoring (PM) for the diagnosis of obstructive sleep apnea (OSA) should be performed only in conjunction with a comprehensive sleep evaluation. Clinical sleep evaluations using PM must be supervised by a practitioner with board certification in sleep medicine or an individual who fulfills the eligibility criteria for the sleep medicine certification examination. PM may be used as an alternative to polysomnography (PSG) for the diagnosis of OSA in patients with a high pretest probability of moderate to severe OSA. PM is not appropriate for the diagnosis of OSA in patients with significant comorbid medical conditions that may degrade the accuracy of PM. PM is not appropriate for the diagnostic evaluation of patients suspected of having comorbid sleep disorders. PM is not appropriate for general screening of asymptomatic populations. PM may be indicated for the diagnosis of OSA in patients for whom in-laboratory PSG is not possible by virtue of immobility, safety, or critical illness. PM may also be indicated to monitor the response to non-CPAP treatments for sleep apnea. At a minimum, PM must record airflow, respiratory effort, and blood oxygenation. The airflow, effort, and oximetric biosensors conventionally used for in-laboratory PSG should be used in PM. The Task Force recommends that PM testing be performed under the auspices of an AASM-accredited comprehensive sleep medicine program with written policies and procedures. An experienced sleep technologist/technician must apply the sensors or directly educate patients in sensor application. The PM device must allow for display of raw data with the capability of manual scoring or editing of automated scoring by a qualified sleep technician/technologist. A board certified sleep specialist, or an individual who fulfills the eligibility criteria for the sleep medicine certification examination, must review the raw data from PM using scoring criteria consistent with current published AASM standards. Under the conditions specified above, PM may be used for unattended studies in the patient's home. Afollow-up visit to review test results should be performed for all patients undergoing PM. Negative or technically inadequate PM tests in patients with a high pretest probability of moderate to severe OSA should prompt in-laboratory polysomnography.
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              The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers.

              Unresolved issues with propofol include whether the pharmacokinetics are linear with dose, are influenced by method of administration (bolus vs. infusion), or are influenced by age. Recently, a new formulation of propofol emulsion, containing disodium edetate (EDTA), was introduced in the United States. Addition of EDTA was found by the manufacturer to significantly reduce bacterial growth. This study investigated the influences of method of administration, infusion rate, patient covariates, and EDTA on the pharmacokinetics of propofol. Twenty-four healthy volunteers aged 26-81 yr were given a bolus dose of propofol, followed 1 h later by a 60-min infusion. Each volunteer was randomly assigned to an infusion rate of 25, 50, 100, or 200 microg x kg(-1) x min(-1). Each volunteer was studied twice under otherwise identical circumstances: once receiving propofol without EDTA and once receiving propofol with EDTA. The influence of the method of administration and of the volunteer covariates was explored by fitting a three-compartment mamillary model to the data. The influence of EDTA was investigated by direct comparison of the measured concentrations in both sessions. The concentrations of propofol with and without EDTA were not significantly different. The concentration measurements after the bolus dose were significantly underpredicted by the parameters obtained just from the infusion data. The kinetics of propofol were linear within the infusion range of 25-200 microg x kg(-1) x min(-1). Age was a significant covariate for Volume2 and Clearance2, as were weight, height, and lean body mass for the metabolic clearance. These results demonstrate that method of administration (bolus vs. infusion), but not EDTA, influences the pharmacokinetics of propofol. Within the clinically relevant range, the kinetics of propofol during infusions are linear regarding infusion rate.
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                Author and article information

                Journal
                Yonsei Med J
                Yonsei Med. J
                YMJ
                Yonsei Medical Journal
                Yonsei University College of Medicine
                0513-5796
                1976-2437
                01 September 2015
                29 July 2015
                : 56
                : 5
                : 1408-1414
                Affiliations
                [1 ]Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.
                [2 ]Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
                Author notes
                Corresponding author: Dr. Dong Woo Han, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Korea. Tel: 82-2-2019-3520, Fax: 82-2-3463-0940, hanesth@ 123456yuhs.ac
                Article
                10.3349/ymj.2015.56.5.1408
                4541675
                26256988
                9b6b06bb-b6a0-460e-b564-a1cd994fdb0e
                © Copyright: Yonsei University College of Medicine 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 11 August 2014
                : 22 October 2014
                : 24 October 2014
                Categories
                Original Article
                Anesthesiology

                Medicine
                airway obstruction,obstructive sleep apnea-hypopnea syndrome,propofol,pharmacodynamic modeling,sedation,target-controlled infusion

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