Hemodynamic Effect of Left Tilting in Cesarean Delivery

NCT ID: NCT03181776

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2018-12-05

Brief Summary

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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

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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.

Conditions

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Cesarean Section Complications Spinal Anesthetic Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study will investigate the effect of different tilting angles on the hemodynamics of full term pregnants before and after spinal anesthesia
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

left lateral tilting in 15 degrees

Intervention Type OTHER

The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge

left lateral tilting in 30 degrees

Intervention Type OTHER

The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge

supine position

Intervention Type OTHER

The mother will be placed in standard supine position

Interventions

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left lateral tilting in 15 degrees

The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge

Intervention Type OTHER

left lateral tilting in 30 degrees

The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge

Intervention Type OTHER

supine position

The mother will be placed in standard supine position

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hasanin

Lecturer of anesthesia and critical care medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Mukhtar, Professor

Role: STUDY_DIRECTOR

Head of research committee section in anesthesia department

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Shash, Professor

Role: CONTACT

+201001033999

Facility Contacts

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ahmed Hasanin, Lecturer

Role: primary

+2010095076954

Other Identifiers

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N-36-2016

Identifier Type: -

Identifier Source: org_study_id

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