Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries

• Published in: Drug design, development and therapy Vol. 18; pp. 1613 - 1625
• Main Authors: Cai, Yu-Hang, Wang, Cheng-Yu, Fang, Yu-Bo, Ma, Hong-Yu, Gao, Yu-Qing, Wang, Zhen, Wu, Junzheng, Lin, Han, Liu, Hua-Cheng
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2024; Dove; Dove Medical Press
• Subjects: Administration, Intranasal; Anesthesia; Anti-Anxiety Agents - administration & dosage; Anti-Anxiety Agents - pharmacology; Anxiety; Anxiety - drug therapy; Benzodiazepines - administration & dosage; Benzodiazepines - pharmacology; Child; Child, Preschool; Clinical trials; Dexmedetomidine; Dexmedetomidine - administration & dosage; Dexmedetomidine - pharmacology; Double-Blind Method; Female; Flumazenil; Humans; Hypnotics and Sedatives - administration & dosage; Hypnotics and Sedatives - pharmacology; Male; Original Research; paediatrics; Parenting; premedication; preoperative anxiety; Remifentanil; remimazolam; Surgery; Tranquilizing drugs; China; paediatrics; remimazolam; dexmedetomidine; premedication; preoperative anxiety
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S461122

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. 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). 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). 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. NCT04720963, January 22, 2021, ClinicalTrials.Gov.