NCT02376192

Maternal Microcirculation & SDF Imaging

Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Initial MicroScan® (Microvision Medical) SDF Measurement	Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.
DRUG	Spinal Anesthesia- Bupivacaine	The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.
DEVICE	Comparative MicroScan® (Microvision Medical) SDF Measurement	A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.
DRUG	Bolus Phenylephrine/Ephedrine Treatment	Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.
DRUG	Phenylephrine Infusion	Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-03-03
• Last updated: 2015-03-03

Locations

1 site across 1 country: Canada