Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "Mild Pre-Eclampsia" | "Analgesics"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02622126
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Sayed Kaoud Abd-Elshafy, Assiut University

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Colloid Pre-Loading on D-Dimer of the Mother and Her Baby During Cesarean Section Under Spinal Anesthesia for Mild Preeclampsia
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: Voluven

Drug: Hyperbaric bupivacaine
Sub arachnoid 10-12 mg hyperbaric bupivacaine
Other Name: 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 Name: 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 Name: Voluven

Drug: Hyperbaric bupivacaine
Sub arachnoid 10-12 mg hyperbaric bupivacaine
Other Name: 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 Name: 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.




Primary Outcome Measures :
  1. Coagulation defect (detection of D-Dimer) of the mother [ Time Frame: 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

  2. Coagulation defect (detection of D-Dimer) of the baby [ Time Frame: 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 :
  1. Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline) [ Time Frame: Post spinal for cesarean delivery, an expected average of 4 hours ]
    fall of > 20% of MAP (mm Hg ) from baseline

  2. Ephedrine treatment (Ephedrine total dosage (mg)) [ Time Frame: Post spinal for cesarean delivery, an expected average of 4 hours ]
    Ephedrine total dosage (mg)

  3. Atropine treatment (atropine total dosage (mg)) [ Time Frame: Post spinal for cesarean delivery, an expected average of 4 hours ]
    atropine total dosage (mg)

  4. Hemoglobin concentration [ Time Frame: Pre and post cesarean delivery, an expected average of 4 hours ]
    Blood samples for detection of hemoglobin concentration gm/dL

  5. Platelet count [ Time Frame: Pre and post cesarean delivery, an expected average of 4 hours ]
    Blood samples for detection of platelet count (109/L )



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622126


Locations
Layout table for location information
Egypt
Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: sayed abd elshafy, MD associate professor

Layout table for additonal information
Responsible Party: Sayed Kaoud Abd-Elshafy, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT02622126     History of Changes
Other Study ID Numbers: IRB0000871175
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by Sayed Kaoud Abd-Elshafy, Assiut University:
Preloading
Colloid
Cesarean section
D-dimer
Hypotension
Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics, Opioid
Analgesics
Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Atropine
Ephedrine
Pseudoephedrine
Morphine
Anesthetics
Bupivacaine
Hydroxyethyl Starch Derivatives
Fibrin fragment D
Pharmaceutical Solutions
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics