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

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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Key information

Conditions

Spinal Anesthesia Cardiovascular Diseases Cesarean Section Hypotension Vascular Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cukurova University, Adana, Saricam, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corrected carotid flow time measurement guided fluid preload

Device

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.

Primary outcomes

The incidence of intra-operative hypotension

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 21, 2023
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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