Coagulation Defect; Bleeding
Conditions
Keywords
Preloading, Colloid, Cesarean section, D-dimer, Hypotension
Brief summary
Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention of spinal hypotension appears more likely to decrease the frequency and severity of associated adverse maternal symptoms than the treatment of established hypotension. Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted standard practice. The choice of fluid depends on individual and institutional habit, material cost (crystalloid is considerably cheaper) and the perceived relative benefits and risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation. Although pregnancy is associated with hypercoagulability, little is known about the effects of colloid preloading on coagulation in pregnant patients.
Detailed description
The patients were divided into two equal group of thirty patients in each group; Control group (normotensive pregnant women) and Mild preeclampsia group. In both groups patients preloaded with 500 mL hydroxyethyl starch (HES) 6% (130/0.4) (Voluven). Spinal anesthesia will be performed with intrathecal 10-12 mg hyperbaric bupivacaine in addition to 200 meg morphine. The patient was placed supine with left lateral tilt to alleviate aortocaval compression. 10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used co loading during the duration of the operation. Blood pressure was measured and recorded every three minutes. If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used. The blood pressure will rechecked 1 minute after each doses of ephedrine. If hypotension persisted after 30 mg of ephedrine, an additional 2 ml/kg of isotonic 0.9 NaCl solutions will be infused rapidly. Maternal hypotension is defined as at least a single administration of ephedrine within the period from induction of spinal anesthesia until transfer to postoperative recovery unit. Reactive hypertension is characterized as a blood pressure 20% greater than baseline mean levels after the use of the vasopressor. Bradycardia is defined as a fall of \>30% of heart rate from baseline or \<50 beats /minute. Bradycardia, and when associated with hypotension it will be treated with 0.5 mg of atropine intravenous. Upon completion of the cesarean section, the subject will be transported to the postanesthesia care unit (PACU).
Interventions
DRUGhydroxyethyl starch (6% 130/0.4)
preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
Sub arachnoid 10-12 mg hyperbaric bupivacaine
DRUGMorphine
Sub arachnoid 200 meg morphine
DRUGIsotonic 0.9 sodium chloride (NaCl) solution
10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation
DRUGEphedrine
If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
DRUGAtropine
Bradycardia (fall of \>30% of heart rate from baseline or \<50 beats /minute and when associated with hypotension) will treated with 0.5 mg of atropine intravenous.
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologist (ASA) status I or II * Aged \>18 years * Singleton pregnancy * Gestational age ≥ 37 weeks * Height ≥ 150 cm and ≤ 180 cm * Weight \> 50 kg and \< 100 kg * Eligible for spinal anesthesia * Elective cesarean delivery
Exclusion criteria
* Multiple pregnancies * Cardiovascular disease cerebrovascular disease * Diabetes Mellitus * Hematological problems * Abnormal coagulation tests * Anticoagulant use * Hemorrhagic syndromes of pregnancy (placenta previa or accidental hemorrhage) * Regular NSAIDS treatment * HELLP syndrome * Severe preeclampsia * Eclampsia * Termination of pregnancy for any cause * Peripheral neuropathy or chronic pain syndrome * Local infection or injury at the needle entry point * Known hypersensitivity reaction to local anesthetic, starch allergy * Height \< 150 cm and \> 180 cm * Weight \< 50 kg and \> 100 kg * Patient refusing spinal anesthesia * Fetal anomalies * Fetal distress or cases with umbilical cord prolapsed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coagulation defect (detection of D-Dimer) of the mother | Pre and post cesarean delivery, an expected average of 90 minutes | Blood samples for detection of D-Dimer were taken from the mother preoperatively (before colloid administration) and another one at the end of the operation |
| Coagulation defect (detection of D-Dimer) of the baby | Pre and post cesarean delivery, an expected average of 90 minutes | Blood sample for detection of D-Dimer was taken from the umbilical cord of the fetus before clamping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atropine treatment (atropine total dosage (mg)) | Post spinal for cesarean delivery, an expected average of 4 hours | atropine total dosage (mg) |
| Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline) | Post spinal for cesarean delivery, an expected average of 4 hours | fall of \> 20% of MAP (mm Hg ) from baseline |
| Platelet count | Pre and post cesarean delivery, an expected average of 4 hours | Blood samples for detection of platelet count (109/L ) |
| Hemoglobin concentration | Pre and post cesarean delivery, an expected average of 4 hours | Blood samples for detection of hemoglobin concentration gm/dL |
| Ephedrine treatment (Ephedrine total dosage (mg)) | Post spinal for cesarean delivery, an expected average of 4 hours | Ephedrine total dosage (mg) |
Countries
Egypt
Outcome results
None listed