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OpenTrials
Completed

NCT Number: NCT06711289

Predicting if the Blood Pressure Will Drop After Spinal Anesthesia Using Ultrasound of the Neck

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.

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Key information

Conditions

Spinal Anesthesia-Induced Hypotension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • History of cerebral trauma
  • Pregnancy
  • Neck complaints
  • Morbid obesity (BMI > 40 kg/m2)

Treatment and study plan

Carotid ultrasound measurement

Diagnostic Test

Pulsed-wave Doppler acquisition of the carotid artery. One acquisition will be made with the slow-speed setting (33 mm/s) and one with the medium-speed setting (66 mm/s).

Vital sign measurement

Diagnostic Test

Measurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia.

spinal anesthesia

Drug

Following the standard of care, the patients received spinal anesthesia. The type and dosage of the local anesthetic were at the discretion of the treating anesthesiologist.

Primary outcomes

  1. 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

  1. Correlation between carotid parameters and blood pressure.

    Time frame: Trough study completion, an average of 30 minutes.

    To determine the correlation between the pre-anesthetic corrected carotid flow time (ccFT) and peak velocity variation on one hand and the maximal changes in systolic and mean arterial blood pressure after spinal anesthesia on the other hand.

Other outcomes

  1. Intra-observer and inter-observer reproducibility of carotid Doppler parameters.

    Time frame: Prior to surgery.

    To determine the intra-observer and inter-observer reproducibility of Doppler parameters derived by two experienced sonographers.

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

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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