{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T14:35:32Z","timestamp":1790778932460,"version":"4.1.0"},"reference-count":39,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2023,4,25]],"date-time":"2023-04-25T00:00:00Z","timestamp":1682380800000},"content-version":"unspecified","delay-in-days":24,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National High Level Hospital Clinical Research Funding","award":["2022-PUMCH-C-011"],"award-info":[{"award-number":["2022-PUMCH-C-011"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,4,12]]},"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Benzodiazepines such as midazolam are widely used to moderately sedate patients during impacted wisdom tooth extraction to reduce anxiety in outpatient surgery. This present protocol was designed to determine whether continuous intravenous remimazolam, a new ultrashort-acting benzodiazepine, produces superior postoperative recovery quality to that of midazolam in patients undergoing extraction of impacted wisdom teeth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This study is a multicentre randomised controlled trial conducted at Peking Union Medical College Hospital, Beijing Anzhen Hospital and Beijing Shijitan Hospital in China. Approximately 150 participants undergoing extraction of impacted mandibular wisdom teeth will be randomly allocated to two groups (remimazolam and midazolam). The participants will be administered standard interventions to ensure they achieve a sedation level of III on the Ramsay sedation scale during the treatment. Preoperative and anaesthesia management and surgical techniques will be standardised for all participants. The primary outcome is recovery time for complete alertness and the secondary outcomes are anterograde amnesia during and after surgery, and interruption during operation for poor compliance or safety concerns.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has been approved by the Ethics Review Committee of Peking Union Medical College Hospital (approval number: ZS-3142), Beijing Anzhen Hospital (approval number: KS2022082) and Beijing Shijitan Hospital (approval number: 2023-4).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05350085\">NCT05350085<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-067908","type":"journal-article","created":{"date-parts":[[2023,4,25]],"date-time":"2023-04-25T12:13:52Z","timestamp":1682424832000},"page":"e067908","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy of continuous intravenous remimazolam versus midazolam in the extraction of impacted wisdom teeth: protocol of a randomised controlled trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05350085","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4303-3270","authenticated-orcid":false,"given":"Lejunzi","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Anesthesiology, Peking Union Medical College Hosptial, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quan","family":"Jing","sequence":"additional","affiliation":[{"name":"Department of Stomatology, Peking Union Medical College Hospital, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7174-9105","authenticated-orcid":false,"given":"Lijian","family":"Pei","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking Union Medical College Hosptial, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking Union Medical College Hosptial, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xia","family":"Ruan","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking Union Medical College Hosptial, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaohui","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking Union Medical College Hosptial, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7990-9003","authenticated-orcid":false,"given":"Yuelun","family":"Zhang","sequence":"additional","affiliation":[{"name":"Medical Research Center, Peking Union Medical College Hospital, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuo","family":"Wan","sequence":"additional","affiliation":[{"name":"Department of Stomatology, Peking Union Medical College Hospital, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuguang","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking Union Medical College Hosptial, Beijing, People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,4,25]]},"reference":[{"key":"2025121313375276000_13.4.e067908.1","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1111\/j.1834-7819.2006.tb00405.x","article-title":"Dental fear in Australia: who\u2019s afraid of the dentist?","volume":"51","author":"Armfield","year":"2006","journal-title":"Aust Dent J"},{"key":"2025121313375276000_13.4.e067908.2","doi-asserted-by":"crossref","first-page":"385","DOI":"10.1038\/sj.bdj.4800777a","article-title":"The impact of dental anxiety on daily living","volume":"189","author":"Cohen","year":"2000","journal-title":"Br Dent J"},{"key":"2025121313375276000_13.4.e067908.3","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6831-7-1","article-title":"The vicious cycle of dental fear: exploring the interplay between oral health, service utilization and dental fear","volume":"7","author":"Armfield","year":"2007","journal-title":"BMC Oral Health"},{"key":"2025121313375276000_13.4.e067908.4","doi-asserted-by":"publisher","DOI":"10.14219\/jada.archive.2005.0027"},{"key":"2025121313375276000_13.4.e067908.5","first-page":"23","article-title":"Changes in sick leave among Swedish dental patients after treatment for dental fear","volume":"10","author":"Hakeberg","year":"1993","journal-title":"Community Dent Health"},{"key":"2025121313375276000_13.4.e067908.6","doi-asserted-by":"publisher","DOI":"10.1111\/adj.12118"},{"key":"2025121313375276000_13.4.e067908.7","doi-asserted-by":"crossref","first-page":"1094","DOI":"10.1111\/pan.13747","article-title":"Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: a systematic review","volume":"29","author":"Manso","year":"2019","journal-title":"Paediatr Anaesth"},{"key":"2025121313375276000_13.4.e067908.8","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1016\/j.jemermed.2018.04.025","article-title":"Systematic review: rectal administration of medications for pediatric procedural sedation","volume":"55","author":"Lam","year":"2018","journal-title":"J Emerg Med"},{"key":"2025121313375276000_13.4.e067908.9","doi-asserted-by":"crossref","first-page":"7289310","DOI":"10.1155\/2016\/7289310","article-title":"Inhalation conscious sedation with nitrous oxide and oxygen as alternative to general anesthesia in precooperative, fearful, and disabled pediatric dental patients: a large survey on 688 working sessions","volume":"2016","author":"Galeotti","year":"2016","journal-title":"Biomed Res Int"},{"key":"2025121313375276000_13.4.e067908.10","doi-asserted-by":"crossref","first-page":"778","DOI":"10.3390\/medicina55120778","article-title":"Conscious sedation in dentistry","volume":"55","author":"Fiorillo","year":"2019","journal-title":"Medicina"},{"key":"2025121313375276000_13.4.e067908.11","doi-asserted-by":"crossref","DOI":"10.1186\/s12903-020-01136-0","article-title":"Conscious sedation for the management of dental anxiety in third molar extraction surgery: a systematic review","volume":"20","author":"Melini","year":"2020","journal-title":"BMC Oral Health"},{"key":"2025121313375276000_13.4.e067908.12","doi-asserted-by":"crossref","first-page":"277","DOI":"10.4103\/0259-1162.171458","article-title":"Conscious sedation: emerging trends in pediatric dentistry","volume":"11","author":"Attri","year":"2017","journal-title":"Anesth Essays Res"},{"key":"2025121313375276000_13.4.e067908.13","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1097\/ACO.0000000000000352","article-title":"Practical considerations in the management of sedation for colonoscopy","volume":"29","author":"Tetzlaff","year":"2016","journal-title":"Curr Opin Anaesthesiol"},{"key":"2025121313375276000_13.4.e067908.14","first-page":"6","article-title":"Comparative evaluation of midazolam and propofol as intravenous sedative agents in the management of unco-operative children","volume":"20","author":"Arya","year":"2002","journal-title":"J Indian Soc Pedod Prev Dent"},{"key":"2025121313375276000_13.4.e067908.15","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1016\/j.ijom.2018.10.014","article-title":"Effects of auriculotherapy and midazolam for anxiety control in patients submitted to third molar extraction","volume":"48","author":"Dellovo","year":"2019","journal-title":"Int J Oral Maxillofac Surg"},{"key":"2025121313375276000_13.4.e067908.16","first-page":"e95","article-title":"Effects of Passiflora incarnata and midazolam for control of anxiety in patients undergoing dental extraction","volume":"22","author":"Dantas","year":"2017","journal-title":"Med Oral Patol Oral Cir Bucal"},{"key":"2025121313375276000_13.4.e067908.17","doi-asserted-by":"publisher","DOI":"10.1097\/01.anes.0000267503.85085.c0"},{"key":"2025121313375276000_13.4.e067908.18","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1007\/s40265-020-01299-8","article-title":"Remimazolam: first approval","volume":"80","author":"Keam","year":"2020","journal-title":"Drugs"},{"key":"2025121313375276000_13.4.e067908.19","doi-asserted-by":"crossref","first-page":"950564","DOI":"10.3389\/fmed.2022.950564","article-title":"Moderate sedation by total intravenous remimazolam-alfentanil vs. propofol-alfentanil for third molar extraction: a prospective randomized controlled trial","volume":"9","author":"Zhao","year":"2022","journal-title":"Front Med"},{"key":"2025121313375276000_13.4.e067908.20","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1016\/j.gie.2018.04.2351","article-title":"A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy","volume":"88","author":"Rex","year":"2018","journal-title":"Gastrointestinal Endoscopy"},{"key":"2025121313375276000_13.4.e067908.21","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/j.chest.2018.09.015","article-title":"Safety and efficacy of remimazolam compared with placebo and midazolam for moderate sedation during bronchoscopy","volume":"155","author":"Pastis","year":"2019","journal-title":"Chest"},{"key":"2025121313375276000_13.4.e067908.22","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1007\/s00540-020-02788-6","article-title":"Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase iib\/III trial","volume":"34","author":"Doi","year":"2020","journal-title":"J Anesth"},{"key":"2025121313375276000_13.4.e067908.23","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1002\/jcph.1552","article-title":"Time-to-event modeling for remimazolam for the indication of induction and maintenance of general anesthesia","volume":"60","author":"Lohmer","year":"2020","journal-title":"J Clin Pharmacol"},{"key":"2025121313375276000_13.4.e067908.24","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejcnurse.2008.10.004"},{"key":"2025121313375276000_13.4.e067908.25","doi-asserted-by":"publisher","DOI":"10.1213\/01.ANE.0000144772.13372.F4"},{"key":"2025121313375276000_13.4.e067908.26","doi-asserted-by":"crossref","first-page":"5248271","DOI":"10.1155\/2016\/5248271","article-title":"How do observational scales correlate the ratings of children\u2019s behavior during pediatric procedural sedation?","volume":"2016","author":"Moura","year":"2016","journal-title":"Biomed Res Int"},{"key":"2025121313375276000_13.4.e067908.27","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1213\/00000539-197011000-00020","article-title":"A postanesthetic recovery score","volume":"49","author":"Aldrete","year":"1970","journal-title":"Anesth Analg"},{"key":"2025121313375276000_13.4.e067908.28","doi-asserted-by":"crossref","first-page":"209","DOI":"10.2334\/josnusd.21-0051","article-title":"Sedation outcomes for remimazolam, a new benzodiazepine","volume":"63","author":"Oka","year":"2021","journal-title":"J Oral Sci"},{"key":"2025121313375276000_13.4.e067908.29","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e318241f68a"},{"key":"2025121313375276000_13.4.e067908.30","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e31823acb95"},{"key":"2025121313375276000_13.4.e067908.31","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1016\/j.dld.2020.10.039","article-title":"Safety and efficacy of remimazolam in high risk colonoscopy: a randomized trial","volume":"53","author":"Rex","year":"2021","journal-title":"Dig Liver Dis"},{"key":"2025121313375276000_13.4.e067908.32","doi-asserted-by":"crossref","first-page":"474","DOI":"10.1111\/jgh.15188","article-title":"Remimazolam tosilate in upper gastrointestinal endoscopy: a multicenter, randomized, non-inferiority, phase III trial","volume":"36","author":"Chen","year":"2021","journal-title":"J Gastroenterol Hepatol"},{"key":"2025121313375276000_13.4.e067908.33","first-page":"4594","article-title":"The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial","volume":"12","author":"Chen","year":"2020","journal-title":"Am J Transl Res"},{"key":"2025121313375276000_13.4.e067908.34","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1007\/s40265-021-01544-8","article-title":"Remimazolam: a review in procedural sedation","volume":"81","author":"Lee","year":"2021","journal-title":"Drugs"},{"key":"2025121313375276000_13.4.e067908.35","unstructured":"Malamed SF . Sedation \uff1a a guide to patient management. St. Louis: Missouri: Elsevier, 2018: 629."},{"key":"2025121313375276000_13.4.e067908.36","first-page":"365","article-title":"Continuous intravenous infusion of midazolam: a clinical study of conscious sedation for dental phobia","volume":"25","author":"Wan","year":"2007","journal-title":"Hua Xi Kou Qiang Yi Xue Za Zhi"},{"key":"2025121313375276000_13.4.e067908.37","article-title":"Midazolam for sedation before procedures","volume":"2016","author":"Conway","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121313375276000_13.4.e067908.38","first-page":"406","article-title":"ED50 for intravenous midazolam-induced amnesia and its duration in surgical patients","volume":"92","author":"Yan","year":"2021","journal-title":"Ann Ital Chir"},{"key":"2025121313375276000_13.4.e067908.39","doi-asserted-by":"publisher","DOI":"10.1016\/j.jocn.2012.11.022"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-067908","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T21:38:01Z","timestamp":1765661881000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-067908"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4]]},"references-count":39,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2023,4,25]]},"published-print":{"date-parts":[[2023,4]]}},"alternative-id":["10.1136\/bmjopen-2022-067908"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-067908","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4]]}}}