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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048497
• Other study ID #: FTCCS
• Status: Completed
• Start date: November 15, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: September 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 5, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension
• Spinal Anesthesia

Intervention

Device:
• Corrected 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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana	Saricam
Turkey	Çukurova University; Faculty of Medicine	Adana	Sariçam

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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