The Role of Carotid Flow Time-Based Fluid Administration in Caesarean Section

Study Overview
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Brief Summary
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It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery. Pregnant women who underwent cesarean section under spinal anesthesia were included in this prospective study. In the preoperative care unit, patients were assigned to two groups according to their baseline FTc values. Patients with baseline FTc < 327 ms were assigned to the first group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. On the other hand, patients with baseline FTc > 327 ms were assigned to the second group, and preload fluid was not administered to these patients. Intraoperative hemodynamic data were recorded for each patient.

Official Title
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The Role of Carotid Flow Time-Based Fluid Administration in the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Caesarean Section

Conditions
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Spinal Anesthesia, Cesarean Section

Intervention / Treatment
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* Device: Corrected carotid flow time measurement guided fluid preload


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-40 years of age pregnant women American Society of Anesthesiologists (ASA) physical status-II patients Uncomplicated, singleton, term pregnancy Elective C/S surgery Exclusion Criteria: Placental disorders Gestational hypertensive disorders Morbid obesity (BMI>39 kg/m2) Carotid stenosis more than 50% Baseline SAP more than 160 mmHg Arrhythmia History of cardiovascular or cerebrovascular disease, and chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) Emergency surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preload<br>Patients with baseline FTc < 327 ms were assigned to the preload group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. | Device: Corrected carotid flow time measurement guided fluid preload<br>* Preoperative FTcs of pregnant women who underwent C/S operation were measured, and those below the cut-off value (327 ms) determined in previous studies were preloaded with Ringer Lactate until FTc was > 327 ms.<br>|
| Non-preload<br>Patients with baseline FTc > 327 ms were assigned to the non-preload group, and preload fluid was not administered to these patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of intra-operative hypotension | Hypotension definitions included systolic arterial pressure (SAP) below 80 mmHg, or mean arterial pressure (MAP) below 65 mmHg, or a decrease in SAP of more than 30% below baseline, or a decrease in MAP of more than 20% below baseline, or any combination of all these definitions. | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Carotid flow time, Preload fluid, Hypotension, Spinal anesthesia