Phenylephrine for Spinal Induced Hypotension
Information source: IWK Health Centre
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypotension
Intervention: Phenylephrine bolus (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: IWK Health Centre Official(s) and/or principal investigator(s):
Ronald B George, MD FRCPC, Principal Investigator, Affiliation: IWK Health Centre
Summary
This study is designed to determine the ED90 for a single dose of phenylephrine for the
treatment of spinal induced hypotension in parturients presenting for an elective CD. The
ED90 is the effective dose at which 90% of subjects will have a "positive" response to
phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary
outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia,
and the presence of hypertension following administration of phenylephrine.
Clinical Details
Official title: Up-Down Determination of the ED90 of Phenylephrine for Spinal Induced Hypotension in Parturients Undergoing Cesarean Delivery
Study design: Treatment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Efficacy Study
Primary outcome: The primary outcome measure is the ED90 for bolus phenylephrine.
Secondary outcome: Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Non-emergent cesarean delivery with planned regional anesthesia (i. e. elective planned
cesarean delivery for malposition, patient choice, cervical pelvic disproportion,
previous cesarean delivery and other diagnosis that require a predetermined cesarean
delivery)
2. American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II -
mild and controlled systemic disease, eg. controlled essential hypertension)
3. Age ≥ 18 years (Standard within the obstetrical literature)
4. Term gestational age
5. English-speaking
Exclusion Criteria:
1. Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose
of local anesthetic less than the standardized dose in this study, typically have an
exaggerated response to vasopressors, and the blood pressure cuff occasionally needs
to be replaced by an intraarterial catheter due to limitations in size)
2. Height < 5'0" (Women < 5'0" are likely to require a dose of local anesthetic less than
the standardized dose in this study)
3. Laboring women
4. Urgent or emergency cesarean delivery
5. Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) >
160mmHg, diastolic blood pressure (DBP) > 110mmHg and/or requiring antihypertensive
treatment or associated with significant proteinuria
6. Severe maternal cardiac disease
7. Diabetes type I
8. Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
9. Fetal anomalies
10. Failed spinal anesthesia
11. Subject enrollment in another study involving a study medication within 30 days of CD
12. Any other physical or psychiatric condition which may impair their ability to
cooperate with study data collection
Locations and Contacts
IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada; Recruiting
Ronald B George, MD FRCPC, Phone: (902) 470-6627, Email: rbgeorge@dal.ca
Ronald B George, MD FRCPC, Principal Investigator
Dolores McKeen, MD MSc FRCPC, Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: October 2008
Last updated: October 27, 2008
|
