Corrected Carotid Flow Time for Predicting Spinal Anesthesia-induced Hypotension

NCT ID: NCT06905535

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Spinal anaesthesia is a standard technique frequently preferred for caesarean section. However, spinal anaesthesia-induced hypotension remains a critical problem causing undesirable maternal symptoms such as nausea, vomiting and dyspnoea and adverse consequences for umbilical acidosis and the fetus. One of the reasons aggravating hypotension is aortocaval compression of the growing uterus and consequent decrease in preload and stroke volume . Therefore, left lateral tilt position is recommended in pregnant women after the 20th gestational week to prevent supine hypotension. This position decreases uterine compression on the vena cava and increases venous return to the heart and thus stroke volume. Recently, carotid artery Doppler has been used to assess stroke volume. Many studies have shown that carotid corrected flow time increases significantly after expansion of intravascular volume in hypovolaemic patients . In one study, it was reported that the change in carotid artery blood flow time induced by passive leg raising predicts fluid sensitivity in critically ill patients. It has been reported that changes in carotid artery blood flow time against hemodynamic interventions (such as Trendelenburg position) reflect maternal hypovolemic status and distinguish hypovolemic patients with a higher risk of spinal anesthesia-related hypotension. The investigators also think that the left lateral tilt position may increase the corrected carotid flow time by affecting hemodynamics and may differentiate the patient with a high risk of hypotension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients undergoing elective cesarean section under spinal anesthesia will be included in the study. Carotid corrected flow time will be measured by Doppler ultrasonography in the supine and left lateral tilt (15°) positions before spinal anesthesia. Flow time will be measured using pulse Doppler waveforms in the long axis of the right common carotid artery. The measured flow time will be calculated as "corrected flow time" using the following Wodey formula; Carotid corrected flow time = measured flow time + \[1.29 (Heart rate - 60)\].

After standard monitoring (Electrocardiography, peripheral oxygen saturation, noninvasive blood pressure measurement), routine spinal anesthesia will be performed without any study-specific changes. The noninvasive blood pressure value measured before spinal anesthesia will be taken as the baseline value and a decrease of 20% or more in this value or a decrease in systolic blood pressure below 100 mmHg will be considered as "spinal anesthesia induced hypotension". Patients will be divided into those who develop spinal anesthesia-induced hypotension and those who do not develop spinal anesthesia-induced hypotension after spinal anesthesia and carotid corrected flow times will be compared between both groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Full-term pregnancy
* physical status II of American Society of Anesthesiologists

Exclusion Criteria

* emergency cesarean section,
* cesarean under general anesthesia
* gestational Diabetes Mellitus
* gestational Hypertension
* preeclampsia,
* cardiovascular disease
* cerebrovascular disease
* chronic kidney disease disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Selcuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

EMİNE ASLANLAR

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

carotis flow

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.