Maternal Microcirculation & SDF Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bolus Phenylephrine/Ephedrine Treatment'

Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants who experience hypotension will receive bolus phenylephrine and/or ephedrine treatment as needed.

Group Type EXPERIMENTAL

Initial MicroScan® (Microvision Medical) SDF Measurement

Intervention Type DEVICE

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

Spinal Anesthesia- Bupivacaine

Intervention Type DRUG

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.

Comparative MicroScan® (Microvision Medical) SDF Measurement

Intervention Type DEVICE

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

Bolus Phenylephrine/Ephedrine Treatment

Intervention Type DRUG

Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.

Phenylephrine Infusion Group

Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Group Type EXPERIMENTAL

Initial MicroScan® (Microvision Medical) SDF Measurement

Intervention Type DEVICE

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

Spinal Anesthesia- Bupivacaine

Intervention Type DRUG

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.

Comparative MicroScan® (Microvision Medical) SDF Measurement

Intervention Type DEVICE

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

Phenylephrine Infusion

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Comparative MicroScan® (Microvision Medical) SDF Measurement

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

Intervention Type DEVICE

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.

Intervention Type DRUG

Phenylephrine Infusion

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No