Back to resultsPediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries (JASayed)
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium Sulphate
Bupivacaine
Dexmedetomidine + Magnesium Sulphate + Bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring dexmedetomidine, magnesium sulphate
Eligibility Criteria
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
Sites / Locations
- Assiut Univeristy HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
group (MG)
group (D)
group (MD)
group (C)
Arm Description
Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine
Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline
Outcomes
Primary Outcome Measures
Time to first analgesic requirement
The time from end of surgery to the first requirement of postoperative analgesia
Secondary Outcome Measures
Postoperative sedation scores
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02487355
Brief Title
Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
Acronym
JASayed
Official Title
Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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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6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
dexmedetomidine, magnesium sulphate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group (MG)
Arm Type
Active Comparator
Arm Description
Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine
Arm Title
group (D)
Arm Type
Active Comparator
Arm Description
Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
Arm Title
group (MD)
Arm Type
Active Comparator
Arm Description
50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
Arm Title
group (C)
Arm Type
Active Comparator
Arm Description
1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine 1 μg/ kg
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulphate
Intervention Description
Magnesium Sulphate 50 mg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
1ml/kg of 0.25%of bupivacaine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine + Magnesium Sulphate + Bupivacaine
Intervention Description
Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine
Primary Outcome Measure Information:
Title
Time to first analgesic requirement
Description
The time from end of surgery to the first requirement of postoperative analgesia
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative sedation scores
Description
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jehan A Sayed, MD
Phone
+2 01006253939
Email
jehan.alloul@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed amir, MD
Phone
+01005689353
Email
dr.amir63@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jehan A Sayed, MD
Organizational Affiliation
assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut Univeristy Hospital
City
Assiut
ZIP/Postal Code
715715
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jehan A sayed, MD
Phone
+2 01006253939
Email
jehan.alloul@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
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