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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06048497
Enrollment
72
Registered
2023-09-21
Start date
2022-11-15
Completion date
2023-07-05
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Spinal Anesthesia

Keywords

Cesarean section, Carotid flow time, Preload fluid, Hypotension, Spinal anesthesia

Brief summary

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.

Interventions

DEVICECorrected carotid flow time measurement guided fluid preload

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.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of intra-operative hypotensionDuring surgeryHypotension 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026