Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries

Study Overview
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Brief Summary
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The study will conduct to compare the efficacy of Magnesium sulphate & dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

Detailed Description
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Official Title
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Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Magnesium Sulphate
* Drug: Bupivacaine
* Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block Exclusion Criteria: Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group (MG)<br>Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine | Drug: Magnesium Sulphate<br>* Magnesium Sulphate 50 mg<br>|
| Active Comparator: group (D)<br>Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine | Drug: Dexmedetomidine<br>* Dexmedetomidine 1 μg/ kg<br>|
| Active Comparator: group (MD)<br>50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine | Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine<br>* Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine<br>|
| Active Comparator: group (C)<br>1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline | Drug: Bupivacaine<br>* 1ml/kg of 0.25%of bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic requirement | The time from end of surgery to the first requirement of postoperative analgesia | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sedation scores | Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, magnesium sulphate