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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- IWK Health Centre
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Microvascular Flow Index (MFI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
- •Coffee/Caffeine intake within 6 hours of SDF measurement
Arms & Interventions
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.
Intervention: Initial MicroScan® (Microvision Medical) SDF Measurement (Device)
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.
Intervention: Spinal Anesthesia- Bupivacaine (Drug)
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.
Intervention: Comparative MicroScan® (Microvision Medical) SDF Measurement (Device)
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.
Intervention: Bolus Phenylephrine/Ephedrine Treatment (Drug)
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.
Intervention: Initial MicroScan® (Microvision Medical) SDF Measurement (Device)
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.
Intervention: Spinal Anesthesia- Bupivacaine (Drug)
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.
Intervention: Comparative MicroScan® (Microvision Medical) SDF Measurement (Device)
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.
Intervention: Phenylephrine Infusion (Drug)
Outcomes
Primary Outcomes
Microvascular Flow Index (MFI)
Time Frame: 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 Outcomes
- Microvascular Flow Index (MFI)(Immediately prior to, and within 10 minutes of induction of spinal anesthesia)
Investigators
Ronald George
Director of Medical Research
IWK Health Centre