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Prediction of Hypotension and Postdural Puncture Headache by Carotid Artery Corrected Flow Time

NCT07372313 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-01-28

No results posted yet for this study

Summary

Anesthesia for cesarean delivery can be provided through general or neuraxial anesthesia (spinal or epidural). Hypotension is a common complication of both methods. Hypotension associated with spinal anesthesia can cause dizziness, nausea, vomiting, restlessness, and confusion in the mother, while also decreasing blood flow to the baby, leading to hypoxia and fetal acidosis. Untreated persistent hypotension poses a life-threatening risk to both mother and baby.

In recent years, ultrasonography has become widely used to assess volume status. Carotid artery corrected flow time (FTc) is primarily affected by left ventricular preload and is related to myocardial contractility and afterload. Therefore, it can predict intraoperative hypotension.

Postdural puncture headache (PDPH) is a relatively common complication after neuraxial blocks. PDPH is generally defined as an orthostatic headache caused by low cerebrospinal fluid pressure accompanied by neck pain, tinnitus, hearing changes, photophobia, and/or nausea. Risk factors include female gender, young age, pregnancy, a previous history of PDPH, low CSF pressure, and low BMI.

This study will be conducted on pregnant women undergoing elective cesarean sections under spinal anesthesia in the cesarean operating room at Erciyes University Faculty of Medicine Hospital. The correlation between preoperative carotid artery FTc levels in pregnant women and the incidence of intraoperative hypotension and postoperative PDPH will be investigated, as will whether FTc levels are a significant predictor of the likelihood of developing intraoperative hypotension and postoperative PDPH. Carotid artery FTc will be measured 1 hour before surgery, and baseline systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peripheral oxygen saturation (SPO2), and heart rate will be recorded in the operating room. Values will be recorded at 1, 2, 3, 5, 10, 12, 15, and 30 minutes after spinal anesthesia. Patients will be assessed postoperatively for postdural puncture headache using a numerical rating scale (NRS) on days 2, 3, and 7.

This study is expected to demonstrate the ability of preoperative FTc to predict hypotension and PDPH, to determine the threshold value for predicting hypotension and PDPH, and to improve or modify the anesthesia method in patients with predicted hypotension and PDPH.

Conditions

  • Hypotension in Pregnant Women
  • Headache in Pregnant Women

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-12-15
Completion
2027-04-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07372313 on ClinicalTrials.gov