Maternal Microcirculation & SDF Imaging

Phase 4

Completed

• Conditions: Pregnancy
• Interventions: Device: Initial MicroScan® (Microvision Medical) SDF Measurement; Drug: Spinal Anesthesia- Bupivacaine; Device: Comparative MicroScan® (Microvision Medical) SDF Measurement; Drug: Phenylephrine Infusion; Drug: Bolus Phenylephrine/Ephedrine Treatment

• Registration Number: NCT02376192
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-09-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine Infusion Group	Phenylephrine Infusion	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.
Phenylephrine Infusion Group	Initial MicroScan® (Microvision Medical) SDF Measurement	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.
Bolus Phenylephrine/Ephedrine Treatment'	Comparative MicroScan® (Microvision Medical) SDF Measurement	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.
Bolus Phenylephrine/Ephedrine Treatment'	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.
Phenylephrine Infusion Group	Comparative MicroScan® (Microvision Medical) SDF Measurement	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.
Bolus Phenylephrine/Ephedrine Treatment'	Initial MicroScan® (Microvision Medical) SDF Measurement	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.
Bolus Phenylephrine/Ephedrine Treatment'	Spinal Anesthesia- Bupivacaine	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.
Phenylephrine Infusion Group	Spinal Anesthesia- Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Microvascular Flow Index (MFI)	Immediately prior to, and within 10 minutes of induction of spinal anesthesia	The change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia

Secondary Outcome Measures

Name	Time	Method
Microvascular Flow Index (MFI)	Immediately prior to, and within 10 minutes of induction of spinal anesthesia	The 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.

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada