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      Effect of general anaesthesia with remimazolam versus propofol on postoperative quality of recovery in patients undergoing ambulatory arthroscopic meniscus repair: a randomised clinical trial

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          Abstract

          Background

          The type of anaesthesia and choice of anaesthetic drugs may affect the quality of recovery after surgery. Remimazolam is a new benzodiazepine with rapid onset and offset, specifically antagonised by flumazenil. This study aimed to compare remimazolam with propofol on the quality of recovery in patients undergoing ambulatory arthroscopic surgery.

          Methods

          Patients aged 18–65 yr and scheduled for ambulatory arthroscopic meniscus repair were recruited and randomly assigned to receive either continuous i.v. infusion of remimazolam or plasma target-controlled infusion of propofol. The quality of recovery-15 (QoR-15) scale was administered on postoperative day 1 (POD1) as the primary outcome. Secondary outcomes included the Athens Insomnia Scale (AIS) scores and cardiovascular variables.

          Results

          In total, 120 patients were randomly assigned to the remimazolam or propofol groups and 114 patients were included in the analysis. The remimazolam group had higher total QoR-15 scores on POD1 (125 [120–127.5] vs 121.5 [119–124], with a median difference of 3 (95% confidence interval: 1–5; P=0.002). Physical independence and psychological support were higher in the remimazolam group (8.5 [8–10] vs 8 [7–9], P=0.043; 17 [13–17] vs 12.5 [12–14], P<0.001). Remimazolam lowered the number of awakenings during the first postoperative night ( P=0.042) and the incidence of hypotension ( P=0.04).

          Conclusions

          Remimazolam-based total i.v. anaesthesia was associated with small improvements in the quality of recovery; however, the improvement was less than the minimally clinically important difference.

          Clinical trial registration

          ChiCTR2100053014.

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          Most cited references36

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          Athens Insomnia Scale: validation of an instrument based on ICD-10 criteria.

          To describe and validate the Athens Insomnia Scale (AIS). The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. It consists of eight items: the first five pertain to sleep induction, awakenings during the night, final awakening, total sleep duration, and sleep quality; while the last three refer to well-being, functioning capacity, and sleepiness during the day. Either the entire eight-item scale (AIS-8) or the brief five-item version (AIS-5), which contains only the first five items, can be utilized. The validation of the AIS was based on its administration to 299 subjects: 105 primary insomniacs, 144 psychiatric patients and 50 non-patient controls. Regarding internal consistency, for both versions of the scale, the Cronbach's alpha was around 0. 90 and the mean item-total correlation coefficient was about 0.70. Moreover, in the factor analysis, the scale emerged as a sole component. The test-retest reliability correlation coefficient was found almost 0.90 at a 1-week interval. As far as external validity is concerned, the correlations of the AIS-8 and AIS-5 with the Sleep Problems Scale were 0.90 and 0.85, respectively. The high measures of consistency, reliability, and validity of the AIS make it an invaluable tool in sleep research and clinical practice.
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            Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15.

            Quality of recovery (QoR) after anesthesia is an important measure of the early postoperative health status of patients. The aim was to develop a short-form postoperative QoR score, and test its validity, reliability, responsiveness, and clinical acceptability and feasibility. Based on extensive clinical and research experience with the 40-item QoR-40, the strongest psychometrically performing items from each of the five dimensions of the QoR-40 were selected to create a short-form version, the QoR-15. This was then evaluated in 127 adult patients after general anesthesia and surgery. There was good convergent validity between the QoR-15 and a global QoR visual analog scale (r = 0.68, P < 0.0005). Construct validity was supported by a negative correlation with duration of surgery (r = -0.49, P < 0.0005), time spent in the postanesthesia care unit (r = -0.41, P < 0.0005), and duration of hospital stay (r = -0.53, P < 0.0005). There was also excellent internal consistency (0.85), split-half reliability (0.78), and test-retest reliability (ri = 0.99), all P < 0.0005. Responsiveness was excellent with an effect size of 1.35 and a standardized response mean of 1.04. The mean ± SD time to complete the QoR-15 was 2.4 ± 0.8 min. The QoR-15 provides a valid, extensive, and yet efficient evaluation of postoperative QoR.
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              The diagnostic validity of the Athens Insomnia Scale.

              To provide documentation for the diagnostic validity of the Athens Insomnia Scale (AIS), a self-assessment psychometric tool which has previously shown high consistency, reliability and external validity for the evaluation of the intensity of sleep difficulty. The AIS was administered to a total of 299 subjects (105 primary insomniacs, 100 psychiatric outpatients, 44 psychiatric inpatients and 50 nonpatient controls) who were also assessed for the ICD-10 diagnosis of "nonorganic insomnia" blindly in terms of the AIS scores. 176 subjects were identified as insomniacs and 123 as noninsomniacs. Logistic regression of AIS total score against the ICD-10 diagnosis of insomnia demonstrated that a score of 6 is the optimum cutoff based on the balance between sensitivity and specificity. When diagnosing individuals with a score of 6 or higher as insomniacs, the scale presents with 93% sensitivity and 85% specificity (90% overall correct case identification). For this cutoff score, in the general population, the scale has a positive predictive value (PPV) of 41% and a negative predictive value (NPV) of 99%. For the same cutoff score, among unselected psychiatric patients, the PPV was found to be 86% and the NPV 92%. Other cutoff scores can be also considered, however, depending on the importance of avoiding false positive or false negative results; for example, for a cutoff score of 10, the PPV in the general population reaches about 90% without the NPV becoming lower than 94%. The AIS can be utilized in clinical practice and research, not only as an instrument to measure the intensity of sleep-related problems, but also as a screening tool in reliably establishing the diagnosis of insomnia.
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                Author and article information

                Contributors
                Journal
                BJA Open
                BJA Open
                BJA Open
                Elsevier
                2772-6096
                28 October 2023
                December 2023
                28 October 2023
                : 8
                : 100237
                Affiliations
                [1 ]Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China
                [2 ]Department of Epidemiology and Biostatistics, School of Public Health, Anhui Medical University, Hefei, China
                Author notes
                []Corresponding author. luyao@ 123456ahmu.edu.cn
                [∗∗ ]Corresponding author. liuxuesheng@ 123456ahmu.edu.cn
                Article
                S2772-6096(23)00116-8 100237
                10.1016/j.bjao.2023.100237
                10630608
                37942055
                c8649fa2-490e-4b88-9053-7bcadbec1fde
                © 2023 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 13 April 2023
                : 24 August 2023
                : 5 October 2023
                Categories
                Original Research Article

                ambulatory,arthroscopic,qor-15,quality of recovery,remimazolam

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