Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Normotensive pregnant women group 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)
preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
Other Names:
Drug: Hyperbaric bupivacaine
Sub arachnoid 10-12 mg hyperbaric bupivacaine
Other Names:
Drug: Morphine
Sub arachnoid 200 meg morphine
Drug: Isotonic 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
Other Names:
Drug: Ephedrine
If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
Drug: Atropine
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.
|
| Active Comparator: Mild preeclampsia pregnant women group 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)
preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
Other Names:
Drug: Hyperbaric bupivacaine
Sub arachnoid 10-12 mg hyperbaric bupivacaine
Other Names:
Drug: Morphine
Sub arachnoid 200 meg morphine
Drug: Isotonic 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
Other Names:
Drug: Ephedrine
If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
Drug: Atropine
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Ephedrine treatment (Ephedrine total dosage (mg)) [Post spinal for cesarean delivery, an expected average of 4 hours]
Ephedrine total dosage (mg)
- Atropine treatment (atropine total dosage (mg)) [Post spinal for cesarean delivery, an expected average of 4 hours]
atropine total dosage (mg)
- Hemoglobin concentration [Pre and post cesarean delivery, an expected average of 4 hours]
Blood samples for detection of hemoglobin concentration gm/dL
- Platelet count [Pre and post cesarean delivery, an expected average of 4 hours]
Blood samples for detection of platelet count (109/L )
Eligibility Criteria
Criteria
Inclusion Criteria:
-
American Society of Anesthesiologist (ASA) status I or II
-
Aged >18 years
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Singleton pregnancy
-
Gestational age ≥ 37 weeks
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Height ≥ 150 cm and ≤ 180 cm
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Weight > 50 kg and < 100 kg
-
Eligible for spinal anesthesia
-
Elective cesarean delivery
Exclusion Criteria:
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Multiple pregnancies
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Cardiovascular disease cerebrovascular disease
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Diabetes Mellitus
-
Hematological problems
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Abnormal coagulation tests
-
Anticoagulant use
-
Hemorrhagic syndromes of pregnancy (placenta previa or accidental hemorrhage)
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Regular NSAIDS treatment
-
HELLP syndrome
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Severe preeclampsia
-
Eclampsia
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Termination of pregnancy for any cause
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Peripheral neuropathy or chronic pain syndrome
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Local infection or injury at the needle entry point
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Known hypersensitivity reaction to local anesthetic, starch allergy
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Height < 150 cm and > 180 cm
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Weight < 50 kg and > 100 kg
-
Patient refusing spinal anesthesia
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Fetal anomalies
-
Fetal distress or cases with umbilical cord prolapsed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine | Assiut | Egypt |
Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: sayed abd elshafy, MD, associate professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB0000871175