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

NCT ID: NCT02622126

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Coagulation Defect; Bleeding

Keywords

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Preloading Colloid Cesarean section D-dimer Hypotension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

hydroxyethyl starch (6% 130/0.4)

Intervention Type DRUG

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

Hyperbaric bupivacaine

Intervention Type DRUG

Sub arachnoid 10-12 mg hyperbaric bupivacaine

Morphine

Intervention Type DRUG

Sub arachnoid 200 meg morphine

Isotonic 0.9 sodium chloride (NaCl) solution

Intervention Type DRUG

10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation

Ephedrine

Intervention Type DRUG

If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.

Atropine

Intervention Type DRUG

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.

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)

Group Type ACTIVE_COMPARATOR

hydroxyethyl starch (6% 130/0.4)

Intervention Type DRUG

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

Hyperbaric bupivacaine

Intervention Type DRUG

Sub arachnoid 10-12 mg hyperbaric bupivacaine

Morphine

Intervention Type DRUG

Sub arachnoid 200 meg morphine

Isotonic 0.9 sodium chloride (NaCl) solution

Intervention Type DRUG

10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation

Ephedrine

Intervention Type DRUG

If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.

Atropine

Intervention Type DRUG

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.

Interventions

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hydroxyethyl starch (6% 130/0.4)

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

Intervention Type DRUG

Hyperbaric bupivacaine

Sub arachnoid 10-12 mg hyperbaric bupivacaine

Intervention Type DRUG

Morphine

Sub arachnoid 200 meg morphine

Intervention Type 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

Intervention Type DRUG

Ephedrine

If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Voluven Marcaine Normal saline

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sayed abd elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB0000871175

Identifier Type: -

Identifier Source: org_study_id