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

The Effects of Colloid Pre-Loading on D-Dimer of the Mother and Her Baby During Cesarean Section Under Spinal Anesthesia for Mild Preeclampsia

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.

Study Overview

• Status: Completed
• Conditions: Coagulation Defect; Bleeding
• Intervention / Treatment: Drug: hydroxyethyl starch (6% 130/0.4); Drug: Hyperbaric bupivacaine; Drug: Morphine; Drug: Isotonic 0.9 sodium chloride (NaCl) solution; Drug: Ephedrine; Drug: Atropine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Voluven; Drug: Hyperbaric bupivacaine; Sub arachnoid 10-12 mg hyperbaric bupivacaine; Other Names: Marcaine; 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: Normal saline; 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: Voluven; Drug: Hyperbaric bupivacaine; Sub arachnoid 10-12 mg hyperbaric bupivacaine; Other Names: Marcaine; 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: Normal saline; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Pre and post cesarean delivery, an expected average of 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)	fall of > 20% of MAP (mm Hg ) from baseline	Post spinal for cesarean delivery, an expected average of 4 hours
Ephedrine treatment (Ephedrine total dosage (mg))	Ephedrine total dosage (mg)	Post spinal for cesarean delivery, an expected average of 4 hours
Atropine treatment (atropine total dosage (mg))	atropine total dosage (mg)	Post spinal for cesarean delivery, an expected average of 4 hours
Hemoglobin concentration	Blood samples for detection of hemoglobin concentration gm/dL	Pre and post cesarean delivery, an expected average of 4 hours
Platelet count	Blood samples for detection of platelet count (109/L )	Pre and post cesarean delivery, an expected average of 4 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Hypotension; Cesarean section; D-dimer; Preloading; Colloid
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Morphine; Atropine; Ephedrine
• Other Study ID Numbers: IRB0000871175