Aswan university
Aswān, Aswan Governorate, 000, Egypt
NCT Number: NCT07140640
Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Phase 4
Aswān, Aswan Governorate, 000, Egypt
This an interventional study comparing effect of Standard dose of Hyperbaric bupivacaine with 20% reduction of dose of Hyperbaric Bupivacaine in Elective Cesarean Delivery.
First, we determaine if the patient ( low - moderate - high ) risk to High spinal complication or not according to : Age-weight-BMI-Height.
Then , Randomly we gave the patients " Full dose of Hyperbaric Bupivacaine OR 20% reduction of hyperbric Bupivacaine " in spinal anaethsia .
Post anesthesia evaluation:
to assess incomplete sensory and/or motor blockade after spinal anesthesia for cesarean section is the Bromage Scale for motor blockade and a sensory block assessment using pinprick or cold sensation.
This scale assesses the degree of motor block in the lower limbs:
Incomplete motor blockade would typically be Bromage 1 or 2.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl).
Other names: Standard dose of hyperbaric bupivacaine
2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl).
Other names: 20% reduced dose of hyperbaric bupivacaine
Time frame: operation time
1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension >30% below baseline).
Time frame: first 20 minutes
1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension >30% below baseline).
Contact information is provided by the study sponsor or research team.
Eman Mahmoud Ismail, Resident
CONTACT
Soudy Salah Hammad, consultant
CONTACT
Aswan University
Other
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