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

Completed

• Conditions: Spinal Anesthesia; Cesarean Section
• Interventions: Device: Corrected carotid flow time measurement guided fluid preload

• Registration Number: NCT06048497
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Primary Completion: 2023-05-20
• Study Completion: 2023-07-05
• Status Verified: 2023-09
• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preload	Corrected carotid flow time measurement guided fluid preload	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.

Primary Outcome Measures

Name	Time	Method
The incidence of intra-operative hypotension	During surgery	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.

Trial Locations

Locations (2)

Cukurova University; 🇹🇷 Adana, Saricam, Turkey

Çukurova University; Faculty of Medicine; 🇹🇷 Adana, Sarıçam, Turkey