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Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Anesthesia
Pregnancy

Treatments

Other: Right lateral position
Other: Supine position
Other: Left lateral position

Study type

Interventional

Funder types

Other

Identifiers

NCT02883075
IRB #16-0119

Details and patient eligibility

About

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).

Full 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.

Enrollment

61 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

61 participants in 3 patient groups

Supine position
Sham Comparator group
Description:
Supine position Supine position after placement of spinal anesthetic
Treatment:
Other: Supine position
Right lateral position
Active Comparator group
Description:
Right lateral position Right lateral after placement of spinal anesthetic
Treatment:
Other: Right lateral position
Left lateral position
Active Comparator group
Description:
Left lateral position Left lateral after placement of spinal anesthetic
Treatment:
Other: Left lateral position

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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