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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02487355 |
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Date of registration:
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29/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
JASayed |
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Scientific title:
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Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02487355 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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jehan A sayed, MD |
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Address:
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Telephone:
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+2 01006253939 |
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Email:
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jehan.alloul@yahoo.com |
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Affiliation:
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Name:
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jehan A Sayed, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt |
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Name:
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Jehan A Sayed, MD |
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Address:
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Telephone:
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+2 01006253939 |
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Email:
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jehan.alloul@yahoo.com |
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Affiliation:
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Key inclusion & exclusion 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
Age minimum:
6 Months
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine
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Drug: Magnesium Sulphate
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Drug: Bupivacaine
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Primary Outcome(s)
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Time to first analgesic requirement
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Postoperative sedation scores
[Time Frame: 24 hours]
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Secondary ID(s)
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IRB000087123
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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