Hemodynamic Effect of Left Tilting in Cesarean Delivery

Hemodynamic Effect of Three Randomized Angles of Left Tilting After Spinal Anesthesia for Cesarean Delivery

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

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications; Spinal Anesthetic Complications
• Intervention / Treatment: Other: left lateral tilting in 15 degrees; Other: left lateral tilting in 30 degrees; Other: supine position

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.

• Study Type: Interventional
• Enrollment (Anticipated): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Shash, Professor; Phone Number: +201001033999; Email: shashahmed@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• full term parturients scheduled for cesarean delivery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: left lateral tilting arm; 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.	Other: left lateral tilting in 15 degrees; The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge; Other: left lateral tilting in 30 degrees; The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge; Other: supine position; The mother will be placed in standard supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output	Cardiac output in liters per minute measured by electrical cardiometry	30 minutes after spinal anesthesia in different angles of left lateral tilting

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Anticipated): November 25, 2018
• Study Completion (Anticipated): December 5, 2018

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: N-36-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No