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Clinical Trials/NCT02883075
NCT02883075
Completed
Not Applicable

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

The University of Texas Medical Branch, Galveston1 site in 1 country61 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
61
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
November 26, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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
  • 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.)

Outcomes

Primary Outcomes

Blood pressure

Time Frame: Immediately before spinal anesthetic placement through placental delivery

Continuous Blood pressure (mmHg) measurements

Heart rate

Time Frame: Immediately before spinal anesthestic placement through placental delivery

Continuous Heart rate (beats per minute) measurements.

Secondary Outcomes

  • Anti-emetic medication(Number of events spinal anesthetic placement through placental delivery)
  • Incidence of vasopressor usage(Spinal anesthetic placement through placental delivery)
  • Incidence of nausea and vomiting(Number of events spinal anesthetic placement through placental delivery)
  • Non Invasive Cardiovascular measurements: stroke volume(Spinal anesthetic placement through placental delivery)
  • Total vasopressor usage(Spinal anesthetic placement through placental delivery)
  • Non Invasive Cardiovascular measurements: cardiac output(Spinal anesthetic placement through placental delivery)
  • Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)(Spinal anesthetic placement through placental delivery)

Study Sites (1)

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