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Maternal Microcirculation & SDF Imaging

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ClinicalTrials.gov Identifier: NCT02376192
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Ronald George, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Device: Initial MicroScan® (Microvision Medical) SDF Measurement Drug: Spinal Anesthesia- Bupivacaine Device: Comparative MicroScan® (Microvision Medical) SDF Measurement Drug: Bolus Phenylephrine/Ephedrine Treatment Drug: Phenylephrine Infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: 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.
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.

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Microvascular Flow Index (MFI) [ Time Frame: 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.


Other Outcome Measures:
  1. Total Vessel Density (TVD) [ Time Frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia ]
  2. Perfused Vessel Density (PVD) [ Time Frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia ]
  3. Proportion of perfused vessels (PPV) [ Time Frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376192


Locations
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Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Investigators
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Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre, Dalhousie University
Publications:
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Responsible Party: Ronald George, Director of Medical Research, IWK Health Centre
ClinicalTrials.gov Identifier: NCT02376192    
Other Study ID Numbers: IWK1010276
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Keywords provided by Ronald George, IWK Health Centre:
Microcirculation
Sidestream Dark Field (SDF) Imaging
Spinal Anesthesia
Phenylephrine
Additional relevant MeSH terms:
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Phenylephrine
Oxymetazoline
Ephedrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants