BMJ open · 2023
Efficacy of continuous intravenous remimazolam versus midazolam in the extraction of impacted wisdom teeth: protocol of a randomised controlled trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wang Lejunzi, Jing Quan, Pei Lijian, Li Mohan, Ruan Xia, Chen Shaohui, Zhang Yuelun, Wan Kuo, Huang Yuguang
Аннотация
INTRODUCTION: 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.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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).
TRIAL REGISTRATION NUMBER: NCT05350085.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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).
TRIAL REGISTRATION NUMBER: NCT05350085.