Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia
Condition: Coagulation Defect; Bleeding
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): hydroxyethyl starch (6% 130/0.4); Hyperbaric bupivacaine; Morphine; Isotonic 0.9 sodium chloride (NaCl) solution; Ephedrine; Atropine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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; 10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation; 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.
Other intervention name(s): Voluven; Marcaine; Normal saline
Intervention MeSH terms: Atropine; Ephedrine; Morphine; Bupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preloading; Colloid; Cesarean section; D-dimer; Hypotension