Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Suspended

• Conditions: Hypovolemia; Hypotension

• Registration Number: NCT02315937
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26
• Study Start: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vena cava inferior collapsibility (in %)	1 hour	vena cava inferior collapsibility: (Maximum vena cava inferior diameter - Minimum vena cava diameter)/maximum vena cava diameter

Trial Locations

Locations (1)

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