Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section
NCT ID: NCT03775655
Last Updated: 2019-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2018-09-01
2019-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LD-DEX
This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml).
Dexmedetomidine
10μg dexmedetomidine will be added to the injectate to be injected intrathecally
Control group
This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).
No interventions assigned to this group
Interventions
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Dexmedetomidine
10μg dexmedetomidine will be added to the injectate to be injected intrathecally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton gestation
* American Society of Anaesthesiologists (ASA) physical status classes II and I
Exclusion Criteria
* Multiple gestation
* Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
* Asthma and allergy to non-steroidal anti-inflammatory drugs
* Conditions that prevent spinal anaesthesia
* Failed spinal block and conversion to general anaesthesia
* A history of established chronic pain
* Drug addiction
* A psychiatric disorder
* Inability to communicate effectively
18 Years
35 Years
FEMALE
Yes
Sponsors
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Menoufia University
OTHER
Responsible Party
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Ahmed Ashraf Nasr
Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University
Principal Investigators
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Mamdoh Lotfy, Prof. Dr.
Role: STUDY_CHAIR
Faculty of Medicine - Menoufia University
Safaa M Helal, Prof. Dr.
Role: STUDY_CHAIR
Faculty of Medicine - Menoufia University
Wesameldin A Soltan, Dr.
Role: STUDY_DIRECTOR
Faculty of Medicine - Menoufia University
Locations
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Menoufia University Hospitals
Shibīn al Kawm, Menoufia, Egypt
Countries
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Other Identifiers
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9076411
Identifier Type: -
Identifier Source: org_study_id
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