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Clinical Trials/NCT06711289
NCT06711289
Completed
Not Applicable

Prediction of Hypotension After Spinal Anesthesia by Doppler Measurement of the Corrected Carotid Flow Time and the Peak Velocity Variation Within the Common Carotid Artery

Catharina Ziekenhuis Eindhoven1 site in 1 country44 target enrollmentApril 12, 2023

Overview

Phase
Not Applicable
Intervention
Carotid ultrasound measurement
Conditions
Spinal Anesthesia-induced Hypotension
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
44
Locations
1
Primary Endpoint
Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension.
Status
Completed
Last Updated
last year

Overview

Brief Summary

After a spinal injection, blood pressure might drop for a short time, similar to what happens with general anesthesia. This drop can be different for each person. An anesthesiologist will use medicine to bring the blood pressure back to normal. If this drop could be predicted in advance, it would help the anesthesiologist treat it faster, making the procedure even safer and preventing side effects like dizziness or nausea.

Registry
clinicaltrials.gov
Start Date
April 12, 2023
End Date
September 29, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Joris Van Houte

Principal investigator

Catharina Ziekenhuis Eindhoven

Eligibility Criteria

Inclusion Criteria

  • Adult patients of either sex who are scheduled for elective surgery under spinal anesthesia,
  • Who fasted for 6 hours or more

Exclusion Criteria

  • Age \<18 years old
  • No informed consent for study participation
  • Contra-indication for spinal anesthesia
  • Emergency surgery
  • Known poor left or right ventricular function / heart failure
  • Moderate to severe valvular disease
  • Atrial fibrillation
  • Pacemaker rhythm
  • Carotid artery stenosis \> 50%
  • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA)

Arms & Interventions

Hypotensive patients

Patients who developed hypotension after the induction of spinal anesthesia.

Intervention: Carotid ultrasound measurement

Hypotensive patients

Patients who developed hypotension after the induction of spinal anesthesia.

Intervention: Vital sign measurement

Hypotensive patients

Patients who developed hypotension after the induction of spinal anesthesia.

Intervention: Spinal anesthesia

Normotensive patients

Patients who did not develop hypotension after the induction of spinal anesthesia.

Intervention: Carotid ultrasound measurement

Normotensive patients

Patients who did not develop hypotension after the induction of spinal anesthesia.

Intervention: Vital sign measurement

Normotensive patients

Patients who did not develop hypotension after the induction of spinal anesthesia.

Intervention: Spinal anesthesia

Outcomes

Primary Outcomes

Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension.

Time Frame: Prior to surgery.

To determine the predictive value of pre-anesthetic corrected carotid flow time (ccFT) and peak velocity variation values for hypotension after induction of spinal anesthesia.

Secondary Outcomes

  • Correlation between carotid parameters and blood pressure.(Trough study completion, an average of 30 minutes.)

Study Sites (1)

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