Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

NCT ID: NCT02883075

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-11-26

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.

Conditions

Pregnancy; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Supine position

Supine position Supine position after placement of spinal anesthetic

Group Type: SHAM_COMPARATOR

Supine position

Intervention Type: OTHER

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

Right lateral position

Right lateral position Right lateral after placement of spinal anesthetic

Group Type: ACTIVE_COMPARATOR

Right lateral position

Intervention Type: OTHER

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

Left lateral position

Left lateral position Left lateral after placement of spinal anesthetic

Group Type: ACTIVE_COMPARATOR

Left lateral position

Intervention Type: OTHER

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

Interventions

Supine position

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

Intervention Type: OTHER

Right lateral position

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

Intervention Type: OTHER

Left lateral position

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

Intervention Type: OTHER

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
• 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ranganathan Govindaraj, MD, FRCA

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston

Locations

UTMB

Galveston, Texas, United States

Countries

United States

Other Identifiers

IRB #16-0119

Identifier Type: -

Identifier Source: org_study_id