Hemodynamic Effect of Left Tilting in Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03181776
• Other study ID #: N-36-2016
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: December 5, 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: Ahmed Shash, Professor
• Phone: +201001033999
• Email: shashahmed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: December 5, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Spinal Anesthetic Complications

Intervention

Other:
• left lateral tilting in 15 degrees
The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge
• left lateral tilting in 30 degrees
The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge
• supine position
The mother will be placed in standard supine position

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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