Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
NCT ID: NCT02961842
Last Updated: 2017-03-22
Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2016-11-20
2017-03-09
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
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
500 mL Colloid Preload
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
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
500 mL Crystalloid Coload
Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
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 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
Coload
1000 mL crystalloid coload. 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 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
1000 mL Crystalloid Coload
Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
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 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
Interventions
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500 mL Colloid Preload
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
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
500 mL Crystalloid Coload
Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
1000 mL Crystalloid Coload
Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
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 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
Eligibility Criteria
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Inclusion Criteria
* Full term, singleton pregnancy
* Elective cesarean delivery under spinal anesthesia
Exclusion Criteria
* Height \<150 cm
* Weight \<60 kg
* Body mass index ≥40 kg/m2
* Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
* Chronic or pregnancy-induced hypertension
* Hemoglobin \<10 gm/dL.
* Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
* Polyhydramnios or known fetal abnormalities
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, principal 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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References
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Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.
Other Identifiers
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R/16.09.64
Identifier Type: -
Identifier Source: org_study_id
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