The Effect of Left Uterine Displacement on Parturient Cardiovascular System

Not Applicable

Completed

• Conditions: Cardiac Output

• Registration Number: NCT02828176
• Lead Sponsor: Cairo University

Brief Summary

The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia

Detailed Description

At operating room, patients will be monitored using non invasive blood, ECG, pulse oximeter and electrical cardiometry. Baseline readings will be taken in supine position then repeated after putting the patient in left lateral position with angle 15 then 30 degrees.

Then two IV lines will be inserted and 500cc crystalloid will be administered. Subarachnoid block will be performed in sitting position under complete aseptic conditions using 25 g spinal needle. Subarachnoid block will be achieved by injecting 10 mg hyperbaric bupivacaine plus 25 ug fentanyl. The block will be considered successful if adequate block reached T4 dermatome.

After successful block the hemodynamic variables will be recorded in the same positions as before (0,15, 30 degrees left uterine tilt).

A minimum number of 61 patients was calculated to have a study power of 80% and alpha error of 0.05.

SPSS Chicago 18 software will be used for data analysis. Categorical data will be presented as frequencies, continuous variables will presented as mean ± standard deviation and will be analyzed using on way analysis of variance (ANOVA) with post-hoc pairwise comparisons using bonferroni test. A P value of 0.05 will be considered statistically significant.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-21
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-06
• Last Update Submitted: 2016-07-09
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs

Exclusion Criteria

• BMI > 35 Kg/m2
• polyhydramnios
• history of impaired cardiac contractility
• valvular heart disease
• cardiac arrhythmias
• hypertensive pregnancy disorders
• fetal abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in cardiac output (L/min) before anesthesia	baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees	measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
change in cardiac output (L/min) after spinal anesthesia	baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees	measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).

Secondary Outcome Measures

Name	Time	Method
change in mean arterial blood pressure (mmHg)	baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block	measured by oscillometry in mmHg
change in systemic vascular resistance (dyn.s/cm5)	baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block