Spinal Anesthesia-induced HypotensionNCT06711289
Predicting if the Blood Pressure Will Drop After Spinal Anesthesia Using Ultrasound of the Neck
An observational study of Spinal Anesthesia-induced Hypotension, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia-induced Hypotension
- What is being tested?
- Carotid ultrasound measurement, Vital sign measurement and Spinal anesthesia
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2023to 29 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective surgery under spinal anesthesia.
Who may be able to join
- Adult patients of either sex who are scheduled for elective surgery under spinal anesthesia,
- Who fasted for 6 hours or more
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Carotid ultrasound measurement, Vital sign measurement, Spinal anesthesia
- Keywords
- Spinal anesthesia-induced hypotension, Carotid Doppler ultrasound, Common carotid artery, Corrected carotid flow time, Peak velocity variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasound measurementDiagnostic 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 measurementDiagnostic test
Measurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia.
Spinal anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypotensive patients | Patients who developed hypotension after the induction of spinal anesthesia. Receives: 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. Receives: Diagnostic Test: Carotid ultrasound measurement; Diagnostic Test: Vital sign measurement; Drug: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to surgery.
Secondary outcomes (1)
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.
Measured: Trough study completion, an average of 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start12 Apr 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia-induced HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joris Van Houte, Catharina Ziekenhuis Eindhoven
- Investigators
- Arthur Bouwman, Professor, Study director, Catharina Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711289
- Sponsor's protocol ID
- W22.234
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients did not give consent that their data would be used in studies other than spinal anesthesia-induced hypotension prediction.
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.
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.
PubMed 40057795
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06711289
- Acronym / sponsor ID
- W22.234
- Conditions
- Spinal Anesthesia-induced Hypotension
- Keywords
- Spinal anesthesia-induced hypotension, Carotid Doppler ultrasound, Common carotid artery, Corrected carotid flow time, Peak velocity variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotensive patients | – | Diagnostic Test: Carotid ultrasound measurement, Diagnostic Test: Vital sign measurement, Drug: Spinal anesthesiaPatients who developed hypotension after the induction of spinal anesthesia. |
| Normotensive patients | – | Diagnostic Test: Carotid ultrasound measurement, Diagnostic Test: Vital sign measurement, Drug: Spinal anesthesiaPatients who did not develop hypotension after the induction of spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective surgery under spinal anesthesia.
Key inclusion criteria (2 listed)
- Adult patients of either sex who are scheduled for elective surgery under spinal anesthesia,
- Who fasted for 6 hours or more
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid ultrasound measurementPulsed-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 | Hypotensive patients, Normotensive patients |
| Vital sign measurementMeasurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia. | Diagnostic test | Hypotensive patients, Normotensive patients |
| Spinal anesthesiaFollowing 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. | Drug | Hypotensive patients, Normotensive patients |
Primary outcome
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.
1 secondary outcome
Correlation between carotid parameters and blood pressure.
Time frame: Trough study completion, an average of 30 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Results publicationJ. 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.
- Derived from this study: PubMed 40057795de 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.
- Individual participant dataSharing planned: No. Patients did not give consent that their data would be used in studies other than spinal anesthesia-induced hypotension prediction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Bouwman, Professor study director
Catharina Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia-induced Hypotension, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension. (time frame: Prior to surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711289, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.