Sevoflurane Induced Emergence Agitation

Study Overview
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Brief Summary
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Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.

Official Title
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Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial

Conditions
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Emergence Agitation

Intervention / Treatment
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* Drug: midazolam
* Drug: alfentanil
* Drug: ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- 8 years American Society of Anesthesiologist (ASA) I-II, Patients undergoing procedures below the umbilicus Exclusion Criteria: cardiac diseases pulmonary diseases hepatic diseases renal diseases psychological or emotional disorders

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midazolam and alfentanil<br>Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral) | Drug: midazolam<br>* Group M<br>Drug: alfentanil<br>* Group MA<br>|
| Active Comparator: midazolam and ketamine<br>Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal) | Drug: midazolam<br>* Group M<br>Drug: ketamine<br>* Group MK<br>|
| Placebo Comparator: midazolam<br>Midazolam 0.5mg/kg | Drug: midazolam<br>* Group M<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium (PAED) score | Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental separation score | Parental separation were evaluated with a 4- point scale in the preoperative period | 7 months | 
| Mask acceptance | The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Sevoflurane, Emergence delirium, General anesthesia, Premedication.