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Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

Measurement of Hemodynamic Variables Under Spinal Anesthesia in a Patient Undergoing Cesarean Section With Varied Positioning - a Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02883075
Enrollment
61
Registered
2016-08-30
Start date
2017-08-01
Completion date
2018-11-26
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pregnancy

Brief summary

Multiple studies have compared spinal anesthetic performed supine versus lateral, with varying results, in parturients having elective cesarean section. Needle positioning during spinal placement has also been examined. No positioning techniques have demonstrated definitive superiority for hemodynamic stability. Investigators propose that following spinal placement in the sitting position if the patient is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic changes caused by sympathectomy related to the subarachnoid block can be avoided. This is the first study to examining the influence of position changes after spinal anesthetic placement in the sitting position, which includes hemodynamic variables not previously studied including cardiac output, TPR (total peripheral resistance) and pulse pressure variation (PPV).

Detailed description

Cesarean section is chosen when natural spontaneous vaginal delivery is either not possible or when the health of the baby or mother is compromised. Cesarean section may be planned, urgent, or performed emergently when the life of the baby or mother is threatened. Cesarean section is performed using different anesthetic techniques including: spinal, epidural, combined spinal and epidural, and general anesthesia. Spinal anesthesia is the most common technique chosen due to its relative safety, rapid onset and avoidance of potential complications from general anesthesia. It is the technique of choice for elective cesarean section unless contraindicated. Spinal anesthesia causes sympathetic blockade followed by sensory and motor blockade. Nerve fiber size explains the speed of onset and differential block. The critical moments during spinal anesthesia come as soon as local anesthetic is injected into the subarachnoid space.

Interventions

OTHERSupine position

Spinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration

Spinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration

Spinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Parturients undergoing elective cesarean section under spinal anesthesia * Singleton intrauterine pregnancy with appropriate gestational age fetus (AGA) at gestational age 37 to 42 weeks

Exclusion criteria

* Large for gestational age, small for gestational age, and multiple gestations * Patients with cardiovascular disease like hypertension, etc. * Non-English or non-Spanish speakers * BMI \>40 * Inadequate or failed blocks and inadvertently high levels of spinal blockade will be dropped from the study * Incarcerated parturients * Expected heavy bleeding (placenta accreta, vascular anomaly, etc.)

Design outcomes

Primary

MeasureTime frameDescription
Heart rateImmediately before spinal anesthestic placement through placental deliveryContinuous Heart rate (beats per minute) measurements.
Blood pressureImmediately before spinal anesthetic placement through placental deliveryContinuous Blood pressure (mmHg) measurements

Secondary

MeasureTime frameDescription
Incidence of vasopressor usageSpinal anesthetic placement through placental deliveryNumber of vasopressor use events will be monitored and recorded.
Total vasopressor usageSpinal anesthetic placement through placental deliveryAll vasopressor administrations with time stamps will be documented.
Incidence of nausea and vomitingNumber of events spinal anesthetic placement through placental deliveryNausea and vomiting incidence and anti-emetic administration with time stamps will be documented.
Non Invasive Cardiovascular measurements: stroke volumeSpinal anesthetic placement through placental deliveryContinuous Stroke volume (mL) measurements
Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)Spinal anesthetic placement through placental deliveryContinuous TPR (total peripheral resistance, dynes\*sec/cm3)measurements
Non Invasive Cardiovascular measurements: cardiac outputSpinal anesthetic placement through placental deliveryContinuous Cardiac output (L/min) measurements
Anti-emetic medicationNumber of events spinal anesthetic placement through placental deliveryAnti-emetic administration with time stamps will be documented.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026