Clinical Trials Directory

Trials / Completed

CompletedNCT02828176

The Effect of Left Uterine Displacement on Parturient Cardiovascular System

Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Cairo University · Academic / Other
Sex
Female
Age
20 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREelectric cardiometryThe following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance. these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees )
PROCEDUREIV line insertiontwo Iv lines are inserted and 500cc crystalloid is administered to parturient .
PROCEDUREspinal anesthesia ( subarachnoid block )Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome.
PROCEDUREelectric cardiometryafter SAB the following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance at three different angles of left uterine lilt (0,15,30 degrees)

Timeline

Start date
2016-01-01
Primary completion
2016-06-01
Completion
2016-06-01
First posted
2016-07-11
Last updated
2016-07-12

Source: ClinicalTrials.gov record NCT02828176. Inclusion in this directory is not an endorsement.