An observational study in Spinal Anesthesia and Cesarean Section, sponsored by Cukurova University. Completed at 2 sites in Turkey. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Cukurova University · Observational
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.
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This study's enrollment of 72 is below the median of 84 across 294 observational studies indexed under Hypotension.
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ASA II pregnant women between the ages of 20 and 40 who were undergoing elective cesarean section, and had uncomplicated singleton term pregnancies, and agreed to participate in the study were included.
Exclusion Criteria:
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
Patients with baseline FTc \> 327 ms were assigned to the non-preload group, and preload fluid was not administered to these patients
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.
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.
Time frame: During surgery
Plan to share: No — All data were anonymized by the local researcher. Therefore, data collection was pseudonymous and the patient's name did not appear on any case report form or other study document. All collected data were kept confidential. This study was conducted in accordance with the revision of the Declaration of Helsinki (2008). International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) was strictly adhered to.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Cukurova University