Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination | Experimental | 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. |
|
| Coload | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 mL Colloid Preload | Drug | 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total ephedrine dose | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension | Hypotension: Systolic blood pressure <80% of baseline | intraoperative |
| Incidence of severe hypotension | Severe hypotension: Systolic blood pressure <70% of baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Tawfik, MD | Mansoura University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Mansoura University Hospitals | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29461392 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Spinal Anesthesia | Procedure | Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle |
|
| Intrathecal Bupivacaine | Drug | Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space |
|
| Intrathecal Fentanyl | Drug | Fentanyl 15 µg will be administered in the subarachnoid space |
|
| 500 mL Crystalloid Coload | Drug | Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection |
|
| 1000 mL Crystalloid Coload | Drug | Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection |
|
| Cesarean Delivery | Procedure | Lower segment cesarean section using the Pfannenstiel incision |
|
| Ultrasound Assessment of the Inferior Vena Cava | Radiation | 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 | Drug | Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively. |
|
| intraoperative |
| Time to the first ephedrine dose | intraoperative |
| Heart rate | intraoperative |
| Inferior vena cava largest and smallest diameters | Baseline, at 1 and 5 minutes after intrathecal injection, delivery |
| Inferior vena cava collapsibility index | Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter | Baseline, at 1 and 5 minutes after intrathecal injection, delivery |
| Incidence of nausea and/or vomiting | intraoperative |
| Neonatal Apgar score | At 1 and 5 minutes after delivery |
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided