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

Completed

• Conditions: Spinal Anesthesia-induced Hypotension
• Interventions: Diagnostic Test: Carotid ultrasound measurement; Diagnostic Test: Vital sign measurement; Drug: Spinal anesthesia

• Registration Number: NCT06711289
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypotensive patients	Carotid ultrasound measurement	Patients who developed hypotension after the induction of spinal anesthesia.
Hypotensive patients	Vital sign measurement	Patients who developed hypotension after the induction of spinal anesthesia.
Hypotensive patients	Spinal anesthesia	Patients who developed hypotension after the induction of spinal anesthesia.
Normotensive patients	Carotid ultrasound measurement	Patients who did not develop hypotension after the induction of spinal anesthesia.
Normotensive patients	Vital sign measurement	Patients who did not develop hypotension after the induction of spinal anesthesia.
Normotensive patients	Spinal anesthesia	Patients who did not develop hypotension after the induction of spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension.	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 Outcome Measures

Name	Time	Method
Correlation between carotid parameters and blood pressure.	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.

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands