Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Conditions
Brief summary
one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.
Interventions
DRUGBupivacaine
Spinal anesthesia with standard dose of bupivacaine
DRUGPrilocaine
Spinal anesthesia with 50 mg dose of Prilocaine.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant \>36 weeks singleton baby * American Society of Anesthesiologists (ASA) physical status 2 * Age : between 18 years old and 35 years old
Exclusion criteria
* Pregnant women with cardiac disease and history of psychiatric illness * Pregnant women who received spinal anesthesia and converted to general anesthesia * Women who have sensitivity to local anesthetics, * Women who have Eclampsia, abruption placenta or placenta previa * Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal arterial blood pressure | at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours | Noninvasive blood pressure will be measured at selected time frame.. Hypotension will be defined as a decrease of systolic blood pressure of at least 20% from baseline. Upon its occurrence, and/or appearance of nausea and dizziness, treatment will be immediately with ephedrine 5mg/ dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of duration of motor block | will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression | the time to motor block regression (duration of motor block), defined as the time between complete block (score 1) after induction of prilocaine or bupivacaine and no motor block (score 6) on the Modified Bromage scale (1, complete motor block; 2, almost complete motor block, ability to move the feet only; 3, ability to move the knees; 4, ability to raise the leg but unable to keep it raised; 5, ability to keep the leg raised for 10 s; 6, no weakness). |
| Total dose of ephedrine | From beginning of administration of spinal anesthesia until complete regression of motor blockade | When hypotension occurred postspinal ephedrine 5mg per dose will be given to restore blood pressure to 90% of its baseline value. |
Countries
Egypt
Outcome results
None listed