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Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled
Yu-Hang Cai1, Cheng-Yu Wang1, Yu-Bo Fang1
1Department 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.
Insights
Intranasal remimazolam effectively reduces preoperative anxiety in children, offering rapid onset with mild sedation. However, it may cause nasal irritation and cooperation issues.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
Background:
- Preoperative anxiety is a significant concern in pediatric surgery.
- Intranasal administration offers a non-invasive route for sedative medications.
- Remimazolam, an ultra-short-acting sedative, has limited investigation in pediatric populations.
Purpose of the Study:
- To evaluate the efficacy of intranasal remimazolam versus dexmedetomidine in alleviating preoperative anxiety in children.
- To compare the sedative effects and cooperation behaviors associated with these agents.
Main Methods:
- A randomized controlled trial involving 90 children undergoing general surgery.
- Three groups received intranasal remimazolam, dexmedetomidine, or distilled water.
- Outcomes included anxiety scores (m-Ypas), sedation levels, cooperation, parental separation anxiety (PSAS), and mask acceptance (MAS).
Main Results:
- Intranasal remimazolam significantly reduced anxiety at 10 minutes and during anesthesia induction compared to placebo and dexmedetomidine.
- Remimazolam induced mild sedation, while dexmedetomidine tended towards deeper sedation.
- Remimazolam improved mask acceptance and reduced parental separation anxiety but caused nasal irritation and poorer cooperation during administration.
Conclusions:
- Both intranasal remimazolam and dexmedetomidine are effective in reducing preoperative anxiety in children.
- Remimazolam offers a rapid onset and mild sedation but is associated with nasal irritation and cooperation challenges.
- Further research is needed to optimize intranasal remimazolam use in pediatric patients.
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-1), Group D (intranasal dexmedetomidine 2 mcg kg-1), 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.
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