Clinical trial NCT03181776: Hemodynamic Effect of Left Tilting in Cesarean Delivery
Official title: Hemodynamic Effect of Three Randomized Angles of Left Tilting After Spinal Anesthesia for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Spinal Anesthetic Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will investigate the effect of different tilting angles on the hemodynamics of full term pregnants before and after spinal anesthesia
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac output
timeFrame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
Secondary outcomes:
measure: cardiac output
timeFrame: before spinal anesthesia in different angles of left lateral tilting
measure: mean arterial blood pressure
timeFrame: before spinal anesthesia in different angles of left lateral tilting
measure: mean arterial blood pressure
timeFrame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
measure: stroke volume
timeFrame: before spinal anesthesia in different angles of left lateral tilting
measure: stroke volume
timeFrame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
measure: systemic vascular resistance
timeFrame: before spinal anesthesia in different angles of left lateral tilting
measure: systemic vascular resistance
timeFrame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
measure: heart rate
timeFrame: before spinal anesthesia in different angles of left lateral tilting
measure: heart rate
timeFrame: 30 minutes after spinal anesthesia in different angles of left lateral tilting
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References: