Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery
NCT ID: NCT03252496
Last Updated: 2021-09-05
Study Results
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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COMPLETED
NA
140 participants
INTERVENTIONAL
2017-08-19
2021-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
Spinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Intrathecal Bupivacaine
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal Fentanyl
Fentanyl 15 μg will be administered in the subarachnoid space
Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision
Ultrasound Assessment of the Inferior Vena Cava
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
250 mL Colloid over 5 minutes
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
500 mL Crystalloid over 55 minutes
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
250 mL Colloid over 60 minutes
After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes
Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Intravenous Syntocinon
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
Spinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Intrathecal Bupivacaine
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal Fentanyl
Fentanyl 15 μg will be administered in the subarachnoid space
Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision
Ultrasound Assessment of the Inferior Vena Cava
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
250 mL Crystalloid over 5 minutes
Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
500 mL Crystalloid over 55 minutes
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
250 mL Crystalloid over 60 minutes
After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Intravenous Syntocinon
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Interventions
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Spinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Intrathecal Bupivacaine
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal Fentanyl
Fentanyl 15 μg will be administered in the subarachnoid space
Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision
Ultrasound Assessment of the Inferior Vena Cava
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
250 mL Colloid over 5 minutes
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
250 mL Crystalloid over 5 minutes
Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
500 mL Crystalloid over 55 minutes
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
250 mL Colloid over 60 minutes
After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes
250 mL Crystalloid over 60 minutes
After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Intravenous Syntocinon
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Elective cesarean delivery under spinal anesthesia
Exclusion Criteria
* Weight \<60 kg
* Body mass index ≥45 kg/m2
* Women presenting in labor
* Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection)
* Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
* Preoperative administration of intravenous hydralazine or magnesium sulphate
* Hemoglobin \<10 gm/dL
* International Normalized Ratio \>1.3
* Platelet count \<100,000 /mm3
* Preoperative serum creatinine \>1.1 mg/dL
19 Years
40 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Mohamed Mohamed Tawfik
Lecturer, Department of anesthesia and surgical intensive care, Primary investigator
Principal Investigators
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Mohamed M Tawfik, MD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University Hospital
Locations
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Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Other Identifiers
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R/17.06.79
Identifier Type: -
Identifier Source: org_study_id
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