Haseki Training and Research Hospital
Istanbul, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06813989
The goal of this observational study is to reveal the relation between carotid flow changes and post-spinal hypotension in pregnant women between the ages of 20-40. The main question it aims to answer is:
Do the carotid flow blood flow measurements and corrected flow time change before and after spinal anaesthesia related to postspinal hypotension? Participants are already receiving spinal anaesthesia to receive a caesarean section. As part of their regular anaesthesia management protocol, they will answer questions about anaesthesia management. The participants will only examined by ultrasound twice.
Interested in participating?
Request Info20 year–40 year
Female
Observational
Istanbul, Turkey (Türkiye)
Location status: Recruiting
In this study, Doppler ultrasound measurements will be taken to evaluate the diameter and flow velocity of the left carotid artery in pregnant women aged 20-40 years, classified as ASA 1-2 term and uncomplicated, upon their arrival at the operating room in the supine position. Measurements will be performed three times at the cricoid level, before the carotid bifurcation, and directly from the arch to mitigate any errors due to the measurer. These measurements will be conducted by the same individual (B.C) and repeated three minutes after returning to the supine position post-spinal anaesthesia, with changes between the two measurements recorded.
The spinal anaesthesia dose will be standardized with 10 mg of heavy bupivacaine and 10 mcg of fentanyl. Hemodynamic data from the time patients enter the operating room until baby delivery will be recorded.
Hypotension during this period will be defined as (1) a decrease in systolic blood pressure >30% or a decrease in mean arterial pressure (MAP) >20% from baseline, or (2) systolic blood pressure <90 mmHg or MAP <65 mmHg. Carotid flow measurements and the amount of crystalloid administered during spinal anaesthesia will be noted in hypotensive and non-hypotensive patients.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals with arrhythmia
Individuals with contraindications for spinal anesthesia
Individuals with Ba MI over 40
Those with a gestational age under 36 weeks or over 41 weeks
Individuals with chronic kidney insufficiency (GRF under 60)
Those with carotid stenosis or a history of previous cerebrovascular events
Patients with placental anomalies
Those initially planned for expected delivery but later switched to cesarean after being taken to trauma.
Patients were taken to the operating room with an emergency cesarean decision
In case of failed spinal anaesthesia, those who switched to general anaesthesia before delivery
The investigator will perform a carotid ultrasound just 2 cm before the carotid bulb and measure the corrected flow time and flow using Doppler and pulse wave analysis. The corrected carotid flow time will be calculated according to Bazett's equation.
Time frame: from spinal anaesthesia till surgical delivery
Hypotension is defined as (1) a decrease in systolic blood pressure >30% or a decrease in mean arterial pressure (MAP) >20% from baseline, or (2) systolic blood pressure <90 mmHg or MAP <65 mmHg.
Time frame: from spinal anaesthesia till surgical delivery
amount of fluid given for co loading during anaesthesia application
Contact information is provided by the study sponsor or research team.
Haseki Training and Research Hospital
Other
Evaluation of the Effectiveness of Carotid Flow Measurements in Predicting Post-Spinal Hypotension in Pregnant Women
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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