Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

Assiut University

Status and phase: Completed; Phase 2

Conditions: Coagulation Defect; Bleeding

Treatments: Drug: Isotonic 0.9 sodium chloride (NaCl) solution; Drug: hydroxyethyl starch (6% 130/0.4); Drug: Morphine; Drug: Hyperbaric bupivacaine; Drug: Ephedrine; Drug: Atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT02622126

IRB0000871175

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Normotensive pregnant women group

Active Comparator group

Description:

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)

Treatment:

Drug: Hyperbaric bupivacaine

Drug: hydroxyethyl starch (6% 130/0.4)

Drug: Isotonic 0.9 sodium chloride (NaCl) solution

Drug: Atropine

Drug: Ephedrine

Drug: Morphine

Mild preeclampsia pregnant women group

Active Comparator group

Description:

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)

Treatment:

Drug: Hyperbaric bupivacaine

Drug: hydroxyethyl starch (6% 130/0.4)

Drug: Isotonic 0.9 sodium chloride (NaCl) solution

Drug: Atropine

Drug: Ephedrine

Drug: Morphine