Intranasal Remimazolam for Premedication in Pediatric Patient

Study Overview
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Brief Summary
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Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various factors like parental separation, unfamiliar surroundings, fear of physicians and needle injections can increase their preoperative anxiety. The researchers conducted the current study to investigate whether intranasal remimazolam can reduce anxiety in children before surgery.

Detailed Description
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children aged 2-5 years old were randomly allocated into three equal groups based on the premedication routes: Group R with intranasal remimazolam, Group D with intranasal dexmedetomidine and Group P with intranasal placebo, respectively.

Official Title
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Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial

Conditions
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Sedative; Anxiety Disorder

Intervention / Treatment
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* Drug: Remimazolam
* Other: Distilled water for injection
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with American Society of Anesthesiologists (ASA) physical status I or II； aged 2-5 years； children with weight for age within the normal range were scheduled surgery with general anesthesia Exclusion Criteria: Children who had gastrointestinal,Cardiovascular or endocrine dysfunction; contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or remimazolam; with any nasal pathology,organ dysfunction; recently respiratory infection, mental disorder; other reasons that researchers hold it is not appropriate to participate in this trial.-

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group P (Placebo group)<br>intranasal placebo about 30min before anesthesia induction | Other: Distilled water for injection<br>* intranasal distilled water for injection<br>|
| Experimental: group R (remimazolam group)<br>intranasal remimazolam about 30min before anesthesia induction | Drug: Remimazolam<br>* intranasal remimazolam<br>|
| Active Comparator: group D (Dexmedetomine group)<br>intranasal dexmedetomidine about 30min before anesthesia induction | Drug: Dexmedetomidine<br>* Intranasal dexmedetomidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of anxiety | The Modified Yale Preoperative Anxiety Scale: The 22-item measure has five behavioural categories: activity, emotional expressivity, alertness and arousal, vocalizations, and interaction with parents. Total scores range from 23.33 through 100 with higher scores indicating greater anxiety. | up to 30 minutes after study drug given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of sedation | Ramsay score Patient anxious or agitated or both Patient cooperative, oriented and tranquil Patient responds to commands only A brisk response to a light glabellar tap A sluggish response to a light glabellar tap No response higher scores mean a higher levels of sedation. | up to 30 minutes after study drug given | 
| the compliance of study drug given | behavior score Clam and cooperative； Anxious but reassurable; Anxious but not reassurable; Crying, or resisting The scores of 1 and 2 signified satisfactory compliance, whereas scores of 3 and 4 were classified as poor compliance. | up to 30 minutes before anesthesia induction | 
| Parental separation anxiety scale | A four-point parental separation anxiety scale as follows: Easy separation, Whimpers, but is easily reassured, not clinging, Cries and cannot be easily reassured, but not clinging to parents, Crying and clinging to parents. The scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 were classified as difficult separation. | up to 30 minutes after study drug given | 
| The degree of cooperation during inhalation anesthesia induction | Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction | intraoperative, (During inhalation anesthesia induction) | 
| Mask acceptance scale，MAS | Mask acceptance scale，MAS terrified, crying, agitated moderate fear, not calmed with reassurance slight fear of mask, easily calmed unafraid, cooperative, accepts mask readily The scores of 3 and 4 signified satisfactory mask acceptable whereas scores of 1 and 2 were classified as poor mask acceptable. | intraoperative, (During inhalation anesthesia induction) | 
| Pediatric anesthesia emergence delirium scale，PAEDs | The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score.pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium. | Within up to 15-30 minutes after child's first eye opening in the postoperative period | 
| Recovery times | The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9 | Within up to 30 minutes after child's first eye opening in the postoperative period | 
| Number of children with adverse effects | Number of children with adverse effects Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions | Up to 24 hours including preoperative, intraoperative, and postoperative periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remimazolam