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Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.
A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Placebo Comparator | Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
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| Dexmedetomidine | Experimental | Patients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table. |
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| Midazolam and Dexmedetomidine | Experimental | Patients were assigned to receive intranasal dexmedetomidine 1ug.kg-1 and oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During inhalation anesthesia induction |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety before induction of anesthesia | 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. | Before preoperative medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huacheng Liu | Contact | 18957755138 | huachengliu@163.com | |
| Yuhang Cai | Contact | 18815091585 | 838097626@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Yuhang Cai | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Dexmedetomidine | Drug | intranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table. |
|
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| Midazolam and Dexmedetomidine | Drug | oral midazolam 0.5mg.kg-1 and intranasal dexmedetomidine 1ug.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table. |
|
|
| The level of sedation | University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable. higher scores mean a higher levels of sedation. | Each 10 minutes during the preoperative period |
| The onset time of satisfactory sedation | The onset time of satisfactory sedation, defined as the time from drug administration to the time when the University of Michigan Sedation Scale reached two points. University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable. higher scores mean a higher levels of sedation. | During the preoperative period |
| Parental separation anxiety scale | A four-point parental separation anxiety scale as follows:
The scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 were classified as difficult separation. | During the preoperative 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 |
| Pediatric anesthesia emergence delirium | 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 |
| Number of children with adverse effects | Number of children with adverse effects
| Up to 24 hours including preoperative, intraoperative, and postoperative periods |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |