Melatonin for Pediatric Emergence Agitation

Study Overview
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Brief Summary
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efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries

Detailed Description
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Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded. Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects

Official Title
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Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics

Conditions
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Emergence Agitation

Intervention / Treatment
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* Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg
* Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg
* Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I scheduled for unilateral inguinal herniorrhaphy parents conscent Exclusion Criteria: allergy to this study drug Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>39 participant will receive melatonin 0.05 mg/kg | Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg<br>* will be administered 1 hour before arrival to operating room<br>Drug: Sevoflurane<br>* for anaesthesia induction 3-8 MAC<br>|
| Active Comparator: 2<br>39 participant will receive melatonin 0.2 mg/kg | Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg<br>* will be administered 1 hour before arrival to operating room<br>Drug: Sevoflurane<br>* for anaesthesia induction 3-8 MAC<br>|
| Active Comparator: 3<br>39 participant will receive melatonin 0.4 mg/kg | Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg<br>* will be administered 1 hour before arrival to operating room<br>Drug: Sevoflurane<br>* for anaesthesia induction 3-8 MAC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence behaviour | change from baseline on a 5 point scale | 5 min, 15 min and 30 min after arrival to recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| yale preoperative anxiety scale | 3 domain scale | before administration of oral premedication and before anaesthesia induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, emergence agitation