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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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2022-12-05
2023-07-05
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
SUPPORTIVE_CARE
DOUBLE
Study Groups
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plan group
bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \\hr.
Bupivacaine Injection
intervention drug will be administred epidurally
epidural group
10 ml of 0.125 % buoivacaine with 0.5 µg\\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\\hr
Dexmedetomidine Injection [Precedex]
interventional drug will be administred either intravenously or epidurally
Bupivacaine Injection
intervention drug will be administred epidurally
intravenous group
continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine
Dexmedetomidine Injection [Precedex]
interventional drug will be administred either intravenously or epidurally
Bupivacaine Injection
intervention drug will be administred epidurally
Interventions
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Dexmedetomidine Injection [Precedex]
interventional drug will be administred either intravenously or epidurally
Bupivacaine Injection
intervention drug will be administred epidurally
Eligibility Criteria
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Inclusion Criteria
* with single fetus scheduled for vaginal delivery
* with cephalic presentation
* requesting labor analgesia.
Exclusion Criteria
* Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
* Twins.
* Malpresentation.
* Preeclampsia or gestational hypertension
* Uncontrolled diabetes HBA1c ≥ 6.5%
* Uncontrolled renal failure
* Uncontrolled liver disease
* Bleeding tendency or coagulopathy.
* Contraindication or patient refusal to epidural block.
* Body mass index ≥ 35.
19 Years
30 Years
FEMALE
Yes
Sponsors
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Menoufia University
OTHER
Responsible Party
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mostafa saieed fahim mansour
lecturer
Principal Investigators
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mostafa M mansour, MD
Role: PRINCIPAL_INVESTIGATOR
Menoufia University
Locations
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Menoufia University Hospitals
Shibīn al Kawm, Menoufia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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11/2022ANET49
Identifier Type: -
Identifier Source: org_study_id
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