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OpenTrials
Completed

NCT Number: NCT02883075

Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UTMB

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

supine position

Other

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

Right Lateral Position

Other

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

Left Lateral Position

Other

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

Primary outcomes

  1. Heart rate

    Time frame: Immediately before spinal anesthestic placement through placental delivery

    Continuous Heart rate (beats per minute) measurements.

  2. Blood pressure

    Time frame: Immediately before spinal anesthetic placement through placental delivery

    Continuous Blood pressure (mmHg) measurements

Secondary outcomes

  1. Incidence of nausea and vomiting

    Time frame: Number of events spinal anesthetic placement through placental delivery

    Nausea and vomiting incidence and anti-emetic administration with time stamps will be documented.

  2. Anti-emetic medication

    Time frame: Number of events spinal anesthetic placement through placental delivery

    Anti-emetic administration with time stamps will be documented.

  3. Incidence of vasopressor usage

    Time frame: Spinal anesthetic placement through placental delivery

    Number of vasopressor use events will be monitored and recorded.

  4. Total vasopressor usage

    Time frame: Spinal anesthetic placement through placental delivery

    All vasopressor administrations with time stamps will be documented.

  5. Non Invasive Cardiovascular measurements: cardiac output

    Time frame: Spinal anesthetic placement through placental delivery

    Continuous Cardiac output (L/min) measurements

  6. Non Invasive Cardiovascular measurements: stroke volume

    Time frame: Spinal anesthetic placement through placental delivery

    Continuous Stroke volume (mL) measurements

  7. Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)

    Time frame: Spinal anesthetic placement through placental delivery

    Continuous TPR (total peripheral resistance, dynes*sec/cm3)measurements

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2016
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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