{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T07:55:41Z","timestamp":1769586941863,"version":"3.49.0"},"reference-count":51,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T00:00:00Z","timestamp":1691971200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Anaesthesiol Scand"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Procedural sedation aims to facilitate a successful diagnostic or therapeutic procedure. The pharmacokinetic properties and pharmacodynamic effects need to be taken into consideration when choosing the ideal sedative. Midazolam and propofol are frequently employed. However, they are associated with respiratory depression with increasing dosage. Also, midazolam has a potentially unpredictable pharmacodynamic response and propofol may cause hypotension and injection site pain. Remimazolam may provide a superior alternative due to its rapid pharmacodynamic profile and insignificant circulatory effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This protocol employs the Preferred Reporting Items for Systematic Reviews and Meta\u2010Analysis guidelines. The review aims to assess the beneficial and harmful clinical effects of remimazolam versus placebo or other sedatives in adult patients requiring sedation in relation to a diagnostic or therapeutic procedure, or due to other circumstances. Three primary outcomes are identified: Sedation success rate, respiratory complications, and hemodynamic complications. Six secondary outcomes are identified: among these are quality of recovery and serious adverse events. All randomized trials are included. The search strategy includes six major biomedical databases. Literature screening and data extraction will be performed independently by two authors. Risk of systemic error will be assessed with Risk of Bias 2 Tool. Risk of random error will be assessed with trial sequential analysis. Heterogeneity will be evaluated by appropriate statistical tests. The certainty of the evidence will be judged using Grading of Recommendations Assessment, Development, and Evaluation. Meta\u2010analysis will be carried out with Rstudio. A \u201cSummary of Findings\u201d table will be presented with our primary and secondary outcome results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The systematic review with up\u2010to\u2010date methodology outlined in this protocol investigates the clinical effects of remimazolam in relation to procedural sedation. The results may guide clinicians in the clinical use of remimazolam.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aas.14316","type":"journal-article","created":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T04:34:20Z","timestamp":1692074060000},"page":"1432-1438","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Remimazolam for sedation: A protocol for a systematic review with meta\u2010analysis, trial sequential analysis, and <scp>GRADE<\/scp> approach"],"prefix":"10.1111","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-7690-7009","authenticated-orcid":false,"given":"Lasse","family":"Stehr\u2010Pingel","sequence":"first","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anaesthesia Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathias","family":"Maagaard","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anaesthesia Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4092-4609","authenticated-orcid":false,"given":"Casper Duevang","family":"Tvarn\u00f8","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anaesthesia Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars Peter Kloster","family":"Andersen","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anaesthesia Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jakob Hessel","family":"Andersen","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anaesthesia Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ole","family":"Mathiesen","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anaesthesia Zealand University Hospital  K\u00f8ge Denmark"},{"name":"Department of Clinical Medicine Copenhagen University  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,14]]},"reference":[{"key":"e_1_2_21_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)68230-5"},{"key":"e_1_2_21_3_1","doi-asserted-by":"publisher","DOI":"10.1155\/2010\/934298"},{"issue":"128","key":"e_1_2_21_4_1","first-page":"437","article-title":"Practice guidelines for moderate procedural sedation and analgesia 2018: A report by the American Society of Anesthesiologists Task Force on moderate procedural sedation and analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American dental association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology*","volume":"2018","journal-title":"Anesthesiology"},{"key":"e_1_2_21_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00540-023-03177-5"},{"key":"e_1_2_21_6_1","doi-asserted-by":"publisher","DOI":"10.4314\/ahs.v22i2.44"},{"key":"e_1_2_21_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2023.1101728"},{"key":"e_1_2_21_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tgie.2016.02.004"},{"key":"e_1_2_21_9_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S375957"},{"key":"e_1_2_21_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.anes.0000267503.85085.c0"},{"key":"e_1_2_21_11_1","doi-asserted-by":"publisher","DOI":"10.15406\/jaccoa.2015.04.00166"},{"key":"e_1_2_21_12_1","first-page":"929","article-title":"Remimazolam, a short\u2010acting GABA(A) receptor agonist for intravenous sedation and\/or anesthesia in day\u2010case surgical and non\u2010surgical procedures","volume":"13","author":"Rogers WK","year":"2010","journal-title":"IDrugs"},{"key":"e_1_2_21_13_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S384155"},{"key":"e_1_2_21_14_1","unstructured":"Compassionate use\u2014medical need. Remimazolam besylate. Induction and Maintenance of General Anesthesia. Information for the patient. Information for the patient. 08\u201008\u20102022 edn.https:\/\/www.famhp.be\/en: Federal Agency for Medicines and Health Products (FAMHP)2022."},{"key":"e_1_2_21_15_1","unstructured":"Compassionate use\u2014medical need. Remimazolam besylate. Sedation of COVID\u201019 patients under artificial ventilation in the Intensive Care Unit. Information for the patient. 08\u201008\u20102022 edn.https:\/\/www.famhp.be\/en: Federal Agency for Medicines and Health Products (FAMHP)2022."},{"key":"e_1_2_21_16_1","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e318241f68a"},{"key":"e_1_2_21_17_1","doi-asserted-by":"publisher","DOI":"10.4097\/kja.22297"},{"key":"e_1_2_21_18_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.641866"},{"key":"e_1_2_21_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"e_1_2_21_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyn188"},{"key":"e_1_2_21_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39489.470347.AD"},{"key":"e_1_2_21_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.655042"},{"key":"e_1_2_21_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/2046-4053-4-1"},{"key":"e_1_2_21_24_1","volume-title":"Cochrane Handbook for Systematic Reviews of Interventions version 6.3","author":"Higgins JPT","year":"2022"},{"key":"e_1_2_21_25_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"e_1_2_21_26_1","unstructured":"Remimazolam for sedation: a protocol for a systematic review with meta\u2010analysis Trial Sequential Analysis and GRADE.https:\/\/www.crd.york.ac.uk\/prospero\/display_record.php?ID=CRD42023420957."},{"key":"e_1_2_21_27_1","unstructured":"Guideline for good clinical practice E6(R2).https:\/\/www.ema.europa.eu\/en: European Medicines Agency 2016."},{"key":"e_1_2_21_28_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-120"},{"key":"e_1_2_21_29_1","article-title":"Rapid response to: RoB 2: a revised tool for assessing risk of bias in randomised trials","volume":"366","author":"Struthers C","year":"2019","journal-title":"BMJ"},{"key":"e_1_2_21_30_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwj069"},{"key":"e_1_2_21_31_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-135-11-200112040-00010"},{"key":"e_1_2_21_32_1","article-title":"Industry sponsorship and research outcome","volume":"2","author":"Lundh A","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_21_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)01085-X"},{"key":"e_1_2_21_34_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta16350"},{"key":"e_1_2_21_35_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1995.03520290060030"},{"key":"e_1_2_21_36_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39465.451748.AD"},{"key":"e_1_2_21_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1186"},{"key":"e_1_2_21_38_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1186"},{"key":"e_1_2_21_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2380"},{"key":"e_1_2_21_40_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.315.7109.629"},{"key":"e_1_2_21_41_1","doi-asserted-by":"publisher","DOI":"10.2307\/2533446"},{"key":"e_1_2_21_42_1","unstructured":"RStudio\u2010Team.RStudio: Integrated Development for R.http:\/\/www.rstudio.com\/2020."},{"key":"e_1_2_21_43_1","doi-asserted-by":"publisher","DOI":"10.1136\/ebmental-2019-300117"},{"key":"e_1_2_21_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2015.09.002"},{"key":"e_1_2_21_45_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780060325"},{"key":"e_1_2_21_46_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.10.007"},{"key":"e_1_2_21_47_1","unstructured":"Kristian ThorlundJE WetterslevJ BrokJ ImbergerG GluudC.User Manual for Trial Sequential Analysis (TSA).https:\/\/ctu.dk\/wp-content\/uploads\/2021\/03\/2017-10-10-TSA-Manual-ENG_ER.pdf: Copenhagen Trial Unit Centre for Clinical Intervention Research 2011: 119"},{"key":"e_1_2_21_48_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0315-7"},{"key":"e_1_2_21_49_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.03.013"},{"key":"e_1_2_21_50_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-9-86"},{"key":"e_1_2_21_51_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-011890"},{"key":"e_1_2_21_52_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.11.026"}],"container-title":["Acta Anaesthesiologica Scandinavica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aas.14316","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,13]],"date-time":"2023-10-13T18:00:46Z","timestamp":1697220046000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/aas.14316"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,14]]},"references-count":51,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1111\/aas.14316"],"URL":"https:\/\/doi.org\/10.1111\/aas.14316","archive":["Portico"],"relation":{},"ISSN":["0001-5172","1399-6576"],"issn-type":[{"value":"0001-5172","type":"print"},{"value":"1399-6576","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,14]]},"assertion":[{"value":"2023-06-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-07-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}