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

NCT06711289 | Completed

• 1 other identifier: W22.234
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia-induced Hypotension

Keywords

Spinal anesthesia-induced hypotension; Carotid Doppler ultrasound; Common carotid artery; Corrected carotid flow time; Peak velocity variation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between carotid parameters and blood pressure.

  Trough study completion, an average of 30 minutes.

Other Outcomes (1)

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

  Prior to surgery.

Study Arms (2)

Hypotensive patients

Patients who developed hypotension after the induction of spinal anesthesia.

Diagnostic Test: Carotid ultrasound measurement; Diagnostic Test: Vital sign measurement; Drug: Spinal anesthesia

Normotensive patients

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

Diagnostic Test: Carotid ultrasound measurement; Diagnostic Test: Vital sign measurement; Drug: Spinal anesthesia

Interventions

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).

Hypotensive patients; Normotensive patients

Vital sign measurement DIAGNOSTIC_TEST

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

Hypotensive patients; Normotensive patients

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.

Hypotensive patients; Normotensive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective surgery under spinal anesthesia.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (2)

• 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.

  BACKGROUND

• de Boer EC, van Houte J, Fernandes CD, Bakkes T, Muehlsteff J, Bouwman RA, Mischi M. Exploring the predictive value of carotid Doppler ultrasound and clinical features for spinal anesthesia-induced hypotension: a prospective observational study. Perioper Med (Lond). 2025 Mar 8;14(1):26. doi: 10.1186/s13741-025-00508-w.

  PMID: 40057795 DERIVED

MeSH Terms

Interventions

Vital Signs; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Arthur Bouwman, Professor

  Catharina Ziekenhuis

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: April 12, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)