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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group P (Placebo group) | Placebo Comparator | intranasal placebo about 30min before anesthesia induction |
|
| group R (remimazolam group) | Experimental | intranasal remimazolam about 30min before anesthesia induction |
|
| group D (Dexmedetomine group) | Active Comparator | intranasal dexmedetomidine about 30min before anesthesia induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | intranasal remimazolam |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The level of sedation | Ramsay score
| up to 30 minutes after study drug given |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu | Second Affiliated Hospital of Wenzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38774484 | Derived | Cai YH, Wang CY, Fang YB, Ma HY, Gao YQ, Wang Z, Wu J, Lin H, Liu HC. Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries. Drug Des Devel Ther. 2024 May 17;18:1613-1625. doi: 10.2147/DDDT.S461122. eCollection 2024. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D007267 | Injections |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007093 | Imidazoles |
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| Distilled water for injection |
| Other |
intranasal distilled water for injection |
|
| Dexmedetomidine | Drug | Intranasal dexmedetomidine |
|
| the compliance of study drug given | behavior score
| up to 30 minutes before anesthesia induction |
| Parental separation anxiety scale | A four-point parental separation anxiety scale as follows:
| 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
| 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
| Up to 24 hours including preoperative, intraoperative, and postoperative periods |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |