NCT06905535

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

December 13, 2024

Last Update Submit

April 7, 2025

Conditions

Keywords

spinal anesthesia induced hypotensioncarotid flow time

Outcome Measures

Primary Outcomes (1)

  • predictive value of the carotid flow time alteration

    rate of prediction

    10-15 minute

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cesarean section in Selcuk University Faculty of Medicine Hospital Gynecology Operating Room

You may qualify if:

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

You may not qualify if:

  • emergency cesarean section,
  • cesarean under general anesthesia
  • gestational Diabetes Mellitus
  • gestational Hypertension
  • preeclampsia,
  • cardiovascular disease
  • cerebrovascular disease
  • chronic kidney disease disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

December 13, 2024

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion

May 30, 2025

Study Completion

June 30, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04