Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

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

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).

Study Overview

• Status: Completed
• Conditions: Pregnancy; Anesthesia
• Intervention / Treatment: Other: Supine position; Other: Right lateral position; Other: Left lateral position

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • UTMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Supine position; Supine position Supine position after placement of spinal anesthetic	Other: Supine position; Spinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration
ACTIVE_COMPARATOR: Right lateral position; Right lateral position Right lateral after placement of spinal anesthetic	Other: Right lateral position; Spinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration
ACTIVE_COMPARATOR: Left lateral position; Left lateral position Left lateral after placement of spinal anesthetic	Other: Left lateral position; Spinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Continuous Heart rate (beats per minute) measurements.	Immediately before spinal anesthestic placement through placental delivery
Blood pressure	Continuous Blood pressure (mmHg) measurements	Immediately before spinal anesthetic placement through placental delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Ranganathan Govindaraj, MD, FRCA, The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): September 26, 2018
• Study Completion (ACTUAL): November 26, 2018

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (ESTIMATE): August 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB #16-0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No