Clinical trial NCT02883075: Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning
Official title: Measurement of Hemodynamic Variables Under Spinal Anesthesia in a Patient Undergoing Cesarean Section With Varied Positioning - a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Anesthesia
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Heart rate
timeFrame: Immediately before spinal anesthestic placement through placental delivery
measure: Blood pressure
timeFrame: Immediately before spinal anesthetic placement through placental delivery
Secondary outcomes:
measure: Incidence of nausea and vomiting
timeFrame: Number of events spinal anesthetic placement through placental delivery
measure: Anti-emetic medication
timeFrame: Number of events spinal anesthetic placement through placental delivery
measure: Incidence of vasopressor usage
timeFrame: Spinal anesthetic placement through placental delivery
measure: Total vasopressor usage
timeFrame: Spinal anesthetic placement through placental delivery
measure: Non Invasive Cardiovascular measurements: cardiac output
timeFrame: Spinal anesthetic placement through placental delivery
measure: Non Invasive Cardiovascular measurements: stroke volume
timeFrame: Spinal anesthetic placement through placental delivery
measure: Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)
timeFrame: Spinal anesthetic placement through placental delivery
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch, Galveston
name: Ranganathan Govindaraj, MD, FRCA
role: PRINCIPAL_INVESTIGATOR
References: