Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Midazolam
* Drug: Dexmedetomidine
* Drug: Midazolam and 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 2-6 years； children with weight for age within the normal range were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes. 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 midazolam; 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: 6 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Midazolam<br>Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. | Drug: Midazolam<br>* oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.<br>* Other names: oral midazolam;|
| Experimental: Dexmedetomidine<br>Patients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table. | Drug: Dexmedetomidine<br>* intranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.<br>* Other names: intranasal dexmedetomidine;|
| Experimental: Midazolam and Dexmedetomidine<br>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. | Drug: Midazolam and Dexmedetomidine<br>* 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.<br>* Other names: combination with intranasal dexmedetomidine and oral midazolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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: -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. | 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 Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Salivation Any adverse effects requiring interventions | Up to 24 hours including preoperative, intraoperative, and postoperative periods |