Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883075
• Other study ID #: IRB #16-0119
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: November 26, 2018

Study information

• Verified date: November 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Anesthesia
• Pregnancy

Intervention

Other:
• Supine position
Spinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration
• Right lateral position
Spinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration
• Left lateral position
Spinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration

Locations

Country	Name	City	State
United States	UTMB	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Continuous Heart rate (beats per minute) measurements.	Immediately before spinal anesthestic placement through placental delivery
Primary	Blood pressure	Continuous Blood pressure (mmHg) measurements	Immediately before spinal anesthetic placement through placental delivery
Secondary	Incidence of nausea and vomiting	Nausea and vomiting incidence and anti-emetic administration with time stamps will be documented.	Number of events spinal anesthetic placement through placental delivery
Secondary	Anti-emetic medication	Anti-emetic administration with time stamps will be documented.	Number of events spinal anesthetic placement through placental delivery
Secondary	Incidence of vasopressor usage	Number of vasopressor use events will be monitored and recorded.	Spinal anesthetic placement through placental delivery
Secondary	Total vasopressor usage	All vasopressor administrations with time stamps will be documented.	Spinal anesthetic placement through placental delivery
Secondary	Non Invasive Cardiovascular measurements: cardiac output	Continuous Cardiac output (L/min) measurements	Spinal anesthetic placement through placental delivery
Secondary	Non Invasive Cardiovascular measurements: stroke volume	Continuous Stroke volume (mL) measurements	Spinal anesthetic placement through placental delivery
Secondary	Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)	Continuous TPR (total peripheral resistance, dynes*sec/cm3)measurements	Spinal anesthetic placement through placental delivery