A Phase 2 interventional study of hydroxyethyl starch (6% 130/0.4) and Hyperbaric bupivacaine in Coagulation Defect; Bleeding, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-11-08.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
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.
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).
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Exclusion Criteria:
Preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6% 130/0.4) (Voluven). Sub arachnoid 10-12 mg hyperbaric bupivacaine Sub arachnoid 200 meg morphine Isotonic 0.9 sodium chloride (NaCl) solution ( 10 ml/kg) will be used as co loading during the duration of the operation Ephedrine 6 me intravenous will be used to treat severe hypotension (fall of \> 20% of mean arterial pressure from baseline) Atropine 0.5 mg intravenous will be used to treat bradycardia (fall of \>30% of heart rate from baseline or \<50 beats /minute and when associated with hypotension)
Drug: hydroxyethyl starch (6% 130/0.4) · Drug: Hyperbaric bupivacaine · Drug: Morphine · Drug: Isotonic 0.9 sodium chloride (NaCl) solution · Drug: Ephedrine · Drug: Atropine
Preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6% 130/0.4) (Voluven). Sub arachnoid 10-12 mg hyperbaric bupivacaine Sub arachnoid 200 meg morphine Isotonic 0.9 sodium chloride (NaCl) solution (NaCl) solution ( 10 ml/kg) will be used as co loading during the duration of the operation Ephedrine 6 me intravenous will be used to treat severe hypotension (fall of \> 20% of mean arterial pressure from baseline) Atropine 0.5 mg intravenous will be used to treat bradycardia (fall of \>30% of heart rate from baseline or \<50 beats /minute and when associated with hypotension)
Drug: hydroxyethyl starch (6% 130/0.4) · Drug: Hyperbaric bupivacaine · Drug: Morphine · Drug: Isotonic 0.9 sodium chloride (NaCl) solution · Drug: Ephedrine · Drug: Atropine
preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
Also known as: Voluven
Sub arachnoid 10-12 mg hyperbaric bupivacaine
Also known as: Marcaine
Sub arachnoid 200 meg morphine
10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation
Also known as: Normal saline
If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
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.
Coagulation defect (detection of D-Dimer) of the mother
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
Time frame: Pre and post cesarean delivery, an expected average of 90 minutes
Coagulation defect (detection of D-Dimer) of the baby
Blood sample for detection of D-Dimer was taken from the umbilical cord of the fetus before clamping
Time frame: Pre and post cesarean delivery, an expected average of 90 minutes
Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)
fall of \> 20% of MAP (mm Hg ) from baseline
Time frame: Post spinal for cesarean delivery, an expected average of 4 hours
Ephedrine treatment (Ephedrine total dosage (mg))
Ephedrine total dosage (mg)
Time frame: Post spinal for cesarean delivery, an expected average of 4 hours
Atropine treatment (atropine total dosage (mg))
atropine total dosage (mg)
Time frame: Post spinal for cesarean delivery, an expected average of 4 hours
Hemoglobin concentration
Blood samples for detection of hemoglobin concentration gm/dL
Time frame: Pre and post cesarean delivery, an expected average of 4 hours
Platelet count
Blood samples for detection of platelet count (109/L )
Time frame: Pre and post cesarean delivery, an expected average of 4 hours
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Assiut University