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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia-induced Hypotension
• Intervention / Treatment: Diagnostic test: Carotid ultrasound measurement; Diagnostic test: Vital sign measurement; Drug: Spinal anesthesia

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective surgery under spinal anesthesia.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypotensive patients; Patients who developed hypotension after the induction of spinal anesthesia.	Diagnostic test: Carotid ultrasound measurement; 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).; Diagnostic test: Vital sign measurement; Measurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia.; Drug: Spinal anesthesia; 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.
Normotensive patients; Patients who did not develop hypotension after the induction of spinal anesthesia.	Diagnostic test: Carotid ultrasound measurement; 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).; Diagnostic test: Vital sign measurement; Measurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia.; Drug: Spinal anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension.	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.	Prior to surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between carotid parameters and blood pressure.	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.	Trough study completion, an average of 30 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-observer and inter-observer reproducibility of carotid Doppler parameters.	To determine the intra-observer and inter-observer reproducibility of Doppler parameters derived by two experienced sonographers.	Prior to surgery.

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Study Director: Arthur Bouwman, Professor, Catharina Ziekenhuis

Publications and helpful links

General Publications

• J. van Houte. The corrected carotid artery flow time and carotid peak velocity variation do not predict spinal anesthesia-induced hypotension: A prospective observational study. JCA Advances. 2024; 1: 1-8.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Common carotid artery; Carotid Doppler ultrasound; Spinal anesthesia-induced hypotension; Corrected carotid flow time; Peak velocity variation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: W22.234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients did not give consent that their data would be used in studies other than spinal anesthesia-induced hypotension prediction.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No