Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

Not Applicable

Completed

• Conditions: Anesthesia; Pregnancy
• Interventions: Other: Left lateral position; Other: Supine position; Other: Right lateral position

• Registration Number: NCT02883075
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Study Start: 2017-08-01
• Primary Completion: 2018-09-26
• Status Verified: 2018-11
• Study Completion: 2018-11-26
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left lateral position	Left lateral position	Left lateral position Left lateral after placement of spinal anesthetic
Supine position	Supine position	Supine position Supine position after placement of spinal anesthetic
Right lateral position	Right lateral position	Right lateral position Right lateral after placement of spinal anesthetic

Primary Outcome Measures

Name	Time	Method
Blood pressure	Immediately before spinal anesthetic placement through placental delivery	Continuous Blood pressure (mmHg) measurements
Heart rate	Immediately before spinal anesthestic placement through placental delivery	Continuous Heart rate (beats per minute) measurements.

Secondary Outcome Measures

Name	Time	Method
Anti-emetic medication	Number of events spinal anesthetic placement through placental delivery	Anti-emetic administration with time stamps will be documented.
Incidence of vasopressor usage	Spinal anesthetic placement through placental delivery	Number of vasopressor use events will be monitored and recorded.
Incidence of nausea and vomiting	Number of events spinal anesthetic placement through placental delivery	Nausea and vomiting incidence and anti-emetic administration with time stamps will be documented.
Non Invasive Cardiovascular measurements: stroke volume	Spinal anesthetic placement through placental delivery	Continuous Stroke volume (mL) measurements
Total vasopressor usage	Spinal anesthetic placement through placental delivery	All vasopressor administrations with time stamps will be documented.
Non Invasive Cardiovascular measurements: cardiac output	Spinal anesthetic placement through placental delivery	Continuous Cardiac output (L/min) measurements
Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)	Spinal anesthetic placement through placental delivery	Continuous TPR (total peripheral resistance, dynes\*sec/cm3)measurements

Trial Locations

Locations (1)

UTMB; 🇺🇸 Galveston, Texas, United States