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

NCT02622126 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-11-08

No results posted yet for this study

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.

Conditions

  • Coagulation Defect; Bleeding

Interventions

DRUG

hydroxyethyl starch (6% 130/0.4)

preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).

DRUG

Hyperbaric bupivacaine

Sub arachnoid 10-12 mg hyperbaric bupivacaine

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

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • sayed abd elshafy, MD · associate professor

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622126 on ClinicalTrials.gov