Hemodynamic Effect of Left Tilting in Cesarean Delivery

Not Applicable

• Conditions: Spinal Anesthetic Complications; Cesarean Section Complications
• Interventions: Other: left lateral tilting in 15 degrees; Other: left lateral tilting in 30 degrees; Other: supine position

• Registration Number: NCT03181776
• Lead Sponsor: Cairo University

Brief Summary

The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block

Detailed Description

Aortocaval compression (ACC) by the gravid uterus is a known physiological phenomenon that is classically claimed to cause supine hypotension in full term pregnant women. ACC has been also mentioned as a possible cause of post-spinal hypotension (PSH) in parturients undergoing cesarean section (CS); however, the evidence for the value of left lateral tilting of parturient in improving hemodynamics is not clear.

The aim of this work is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after subarachnoid block (SAB).

Hemodynamic variables will be taken before SAB in three angles (zero angle, 15 degree angle, and 30 degree angles) of left lateral tilt.

Patients will receive normal SAB after prophylactic vasopressor adminstration (either 15 mg ephedrine or 1.5 mcg/Kg phenylephrine intravenous bolus) then hemodynamic variables will measured again after SAB in the same three angles. The sequence of the tilting angles will be randomized.

Another measure will be taken after delivery of the fetus. SAB will be done in sitting position under complete asepsis using 25 g spinal needle with crystalloid infusion of 500 mL. SAB will be achieved by intrathecal injection of 10 mg hyperbaric Bupivacaine plus 25ug fentanyl. Success of SAB will be tested within five minutes after drug injection. SAB will be considered successful if adequate block reached T4 dermatome.

Cardiac output and stroke volume will be measured using electrical cardiometry device.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Study Start: 2017-06-22
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-09
• Primary Completion: 2018-11-25
• Study Completion: 2018-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• full term parturients scheduled for cesarean delivery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
left lateral tilting arm	left lateral tilting in 15 degrees	all patients will be put in three angles of left lateral tilt in randomized order (supine position - left lateral tilting in 15 degrees - and left lateral tilting in 30 degrees) and the hemodynamic data will be compared in the three angles.
left lateral tilting arm	left lateral tilting in 30 degrees	all patients will be put in three angles of left lateral tilt in randomized order (supine position - left lateral tilting in 15 degrees - and left lateral tilting in 30 degrees) and the hemodynamic data will be compared in the three angles.
left lateral tilting arm	supine position	all patients will be put in three angles of left lateral tilt in randomized order (supine position - left lateral tilting in 15 degrees - and left lateral tilting in 30 degrees) and the hemodynamic data will be compared in the three angles.

Primary Outcome Measures

Name	Time	Method
Cardiac output	30 minutes after spinal anesthesia in different angles of left lateral tilting	Cardiac output in liters per minute measured by electrical cardiometry

Secondary Outcome Measures

Name	Time	Method
systemic vascular resistance	30 minutes after spinal anesthesia in different angles of left lateral tilting	measured in mmHg × min / mL by electrical cardiometry
heart rate	30 minutes after spinal anesthesia in different angles of left lateral tilting	measured in beat per minute
stroke volume	30 minutes after spinal anesthesia in different angles of left lateral tilting	stroke volume in milliliters measured by electrical cardiometry
mean arterial blood pressure	30 minutes after spinal anesthesia in different angles of left lateral tilting	mean arterial blood pressure measured by non-invasive monitor
cardiac output	before spinal anesthesia in different angles of left lateral tilting	Cardiac output in liters per minute measured by electrical cardiometry

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt