DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY
Phase 4
Recruiting
- Conditions
- Painless Vainal Labour
- Interventions
- Registration Number
- NCT05840328
- Lead Sponsor
- Menoufia University
- Brief Summary
compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- Full term (≥ 37 weeks) healthy primigravida parturients ASA2
- with single fetus scheduled for vaginal delivery
- with cephalic presentation
- requesting labor analgesia.
Exclusion Criteria
- Allergy to dexmetomidine.(based on previous history)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description plan group Bupivacaine Injection 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. epidural group Dexmedetomidine Injection [Precedex] 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 intravenous group Dexmedetomidine Injection [Precedex] continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine epidural group Bupivacaine Injection 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 intravenous group Bupivacaine Injection continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine
- Primary Outcome Measures
Name Time Method pain relief on delivery VAS score from 0 to 10
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Menoufia University Hospitals
🇪🇬Shibīn Al Kawm, Menoufia, Egypt