鼻腔内给予雷米佐仑和右美托咪定的术前抗焦虑和镇静作用：一项在接受普外科手术的儿童中进行的随机对照临床研究。
Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries.
机构信息
Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University; Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.
Laboratory Medicine Center, Allergy Center, Department of Transfusion Medicine, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, People's Republic of China.
出版信息
Drug Des Devel Ther. 2024 May 17;18:1613-1625. doi: 10.2147/DDDT.S461122. eCollection 2024.
PURPOSE
Remimazolam, an ultra-short-acting and fast-metabolized sedative, has only been sporadically investigated in children. This study was performed to determine the beneficial effects of intranasal remimazolam or dexmedetomidine on preoperative anxiety in children undergoing general surgeries.
PATIENTS AND METHODS
Ninety children were randomly and equally assigned to Group R (intranasal remimazolam 1.5mg kg), Group D (intranasal dexmedetomidine 2 mcg kg), and Group C (intranasal distilled water). The primary outcomes were the preoperative anxiety scores using the modified Yale preoperative anxiety scale (m-Ypas). The secondary outcomes included the cooperation behaviour of intranasal drug application, preoperative sedation levels, parental separation anxiety scores (PSAS), and mask acceptance scores (MAS).
RESULTS
Group R showed a significant low anxiety at 10 min after intranasal premedication (vs group C, P=0.010; vs group D, P = 0.002) and at anaesthesia induction (vs group C, P = 0.004). Group D showed a significantly low anxiety score only prior to anaesthesia induction (vs group C, P = 0.005). Most children in group R achieved mild sedation at 10 min (vs group C, P < 0.001; vs group D, P < 0.001), with a few progressing to deep sedation afterwards, while group D tended toward deep sedation. Compared to Group C, patients in Group R performed significantly better on the MAS (P = 0.014) and PSAS (P = 0.008). However, remimazolam did cause poor cooperation behavior to the intranasal application due to its mucosal irritation (vs group C, P = 0.001; vs group D, P = 0.010).
CONCLUSION
Both intranasal remimazolam and dexmedetomidine can effectively alleviate preoperative anxiety in children. While intranasal remimazolam has a rapid onset, it produces only mild sedation and causes substantial nasal irritation.
TRIAL REGISTRATION
NCT04720963, January 22, 2021, ClinicalTrials.Gov.
目的
雷米唑仑是一种超短效、快速代谢的镇静剂，在儿童中仅偶有研究。本研究旨在确定鼻内给予雷米唑仑或右美托咪定对行全身手术的儿童术前焦虑的有益作用。
患者和方法
90 名儿童被随机平均分为 R 组（鼻内给予雷米唑仑 1.5mg/kg）、D 组（鼻内给予右美托咪定 2μg/kg）和 C 组（鼻内给予蒸馏水）。主要结局指标为改良耶鲁术前焦虑量表（m-Ypas）评估的术前焦虑评分。次要结局指标包括鼻内用药的合作行为、术前镇静水平、父母分离焦虑评分（PSAS）和面罩接受评分（MAS）。
结果
R 组在鼻内预给药后 10 分钟（与 C 组相比，P=0.010；与 D 组相比，P=0.002）和麻醉诱导时（与 C 组相比，P=0.004）表现出显著较低的焦虑。D 组仅在麻醉诱导前表现出较低的焦虑评分（与 C 组相比，P=0.005）。R 组大多数儿童在 10 分钟时达到轻度镇静（与 C 组相比，P＜0.001；与 D 组相比，P＜0.001），随后少数进展为深度镇静，而 D 组则倾向于深度镇静。与 C 组相比，R 组患儿 MAS（P=0.014）和 PSAS（P=0.008）评分显著更好。然而，雷米唑仑由于其黏膜刺激性而导致鼻内应用的合作行为明显较差（与 C 组相比，P=0.001；与 D 组相比，P=0.010）。
结论
鼻内给予雷米唑仑和右美托咪定均可有效缓解儿童术前焦虑。虽然鼻内给予雷米唑仑起效迅速，但仅产生轻度镇静作用，且引起明显的鼻刺激。
试验注册
NCT04720963，2021 年 1 月 22 日，ClinicalTrials.Gov。
Zotero 插件