Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02376192
Enrollment
32
Registered
2015-03-03
Start date
2014-01-31
Completion date
2014-12-31
Last updated
2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Microcirculation, Sidestream Dark Field (SDF) Imaging, Spinal Anesthesia, Phenylephrine

Brief 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.

Interventions

DEVICEInitial MicroScan® (Microvision Medical) SDF Measurement

Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.

DRUGSpinal 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.

DEVICEComparative MicroScan® (Microvision Medical) SDF Measurement

A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.

DRUGBolus 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.

Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Sponsors

IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease) * Singleton pregnancies * 36-42 weeks gestation * Non-labouring * Scheduled cesarean delivery * English speaking * Age 18-45 years

Exclusion criteria

* Cardiovascular disease * Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia) * Allergy to phenylephrine, or any other standardized medication * Obesity (BMI \> 35 kg/m2) * Diabetes Mellitus type 1 * Smoker * Coffee/Caffeine intake within 6 hours of SDF measurement

Design outcomes

Primary

MeasureTime frameDescription
Microvascular Flow Index (MFI)Immediately prior to, and within 10 minutes of induction of spinal anesthesiaThe change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia

Secondary

MeasureTime frameDescription
Microvascular Flow Index (MFI)Immediately prior to, and within 10 minutes of induction of spinal anesthesiaThe difference between the MFI measured within 10 minutes following the induction of spinal anesthesia in participants who receive phenylephrine via a continuous infusion for the prevention of spinal anesthesia-induced hypotension compared to those who may receive phenylephrine boluses for treatment of spinal anesthesia-induced hypotension.

Other

MeasureTime frame
Total Vessel Density (TVD)Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Perfused Vessel Density (PVD)Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Proportion of perfused vessels (PPV)Immediately prior to, and within 10 minutes of induction of spinal anesthesia

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026