Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
JASayed
Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 29, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 26, 2017
September 1, 2017
2.6 years
June 29, 2015
September 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first analgesic requirement
The time from end of surgery to the first requirement of postoperative analgesia
24 hours
Secondary Outcomes (1)
Postoperative sedation scores
24 hours
Study Arms (4)
group (MG)
ACTIVE COMPARATORMagnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine
group (D)
ACTIVE COMPARATORDexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
group (MD)
ACTIVE COMPARATOR50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
group (C)
ACTIVE COMPARATOR1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline
Interventions
Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut Univeristy Hospital
Asyut, 715715, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jehan A Sayed, MD
assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor (Anesthesiology and Critical Care)- College of Medicine
Study Record Dates
First Submitted
June 29, 2015
First Posted
July 1, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
September 26, 2017
Record last verified: 2017-09