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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03653442
Other study ID # Reg. 2018/0051
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 10, 2018
Est. completion date January 1, 2020

Study information

Verified date March 2020
Source Papa Giovanni XXIII Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can be burdened by maternal hypotension with significant maternal and foetal implications.


Description:

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Study Design


Locations

Country Name City State
Italy Asst Papa Giovanni Xxiii Bergamo

Sponsors (1)

Lead Sponsor Collaborator
Papa Giovanni XXIII Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stress tests and Systolic blood pressure to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Primary Stress tests and Diastolic blood pressure to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Diastolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Primary Stress tests and Mean arterial blood pressure to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Mean arterial blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Primary Stress tests and Heart rate to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Heart rate in beats per minute) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Primary Stress tests and Cardiac output to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Cardiac output in L/min) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Primary Stress tests and Stroke volume to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Stroke volume in mL/beat) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Primary Stress tests and Systemic vascular resistance to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systemic vascular resistance in dynes - sec/cm^5) and neuraxial anaesthesia induced hypotension (clinical end point) before Caesarean section
Secondary Neuraxial induced hypotension Neuraxial induced hypotension is defined as a reduction of SBP < 100 mmHg or a decrease by 20 - 30%, compared to basal value from immediately after induction of spinal anaesthesia to 15 minutes later
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