Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02315937

Acronym

SATE

Enrollment

Registered

2014-12-12

Start date

2016-09-30

Completion date

2016-12-31

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Hypovolemia

Brief summary

Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This hypotension is often treated with fluid infusion. However, especially in elderly patients, high volume fluid infusion can lead to fluid overload. The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known. Hence, therapy for hypotension after spinal anesthesia might not be adequate. With transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to monitor fluid responsiveness and guide fluid management. Objective: This study has two main objectives. The first is to explore the effects of spinal anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter and collapsibility. The second goal is to test the interrater variability transthoracic echocardiography exams when performed by (trained) anesthesiologists. Furthermore, the correlation between vena cava inferior collapsibility and the occurence and degree of hypotension (defined as a decrease from baseline of \>20% or a systolic pressure \< 90 mmHg) after spinal anesthesia will be explored.

Interventions

PROCEDUREtransthoracic echocardiography

measurement of inferior vena cava diameter during inspiration and expiration using transthoracic echocardiography

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult age (\>18 years) * Written informed consent * Minor surgery under the umbilicus, e.g. herniorrhaphy, transurethral resection of bladder or prostate, orthopaedic procedures * ASA class I or II

Exclusion criteria

* No informed consent * ASA class III or higher * Obstetric surgery * Emergency procedures * Pre-existing neurological injury or disease * Contra-indications for spinal anesthesia (e.g. coagulation abnormalities)

Design outcomes

Primary

Measure	Time frame	Description
vena cava inferior collapsibility (in %)	1 hour	vena cava inferior collapsibility: (Maximum vena cava inferior diameter - Minimum vena cava diameter)/maximum vena cava diameter

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026