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

NCT ID: NCT06711289

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-12

Study Completion Date

2023-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Anesthesia-induced Hypotension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypotensive patients

Patients who developed hypotension after the induction of spinal anesthesia.

Carotid ultrasound measurement

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Spinal anesthesia

Intervention Type 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.

Normotensive patients

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

Carotid ultrasound measurement

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Spinal anesthesia

Intervention Type 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.

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Vital sign measurement

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Joris Van Houte

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur Bouwman, Professor

Role: STUDY_DIRECTOR

Catharina Ziekenhuis

Locations

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Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type 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.

Reference Type DERIVED
PMID: 40057795 (View on PubMed)

Other Identifiers

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W22.234

Identifier Type: -

Identifier Source: org_study_id