Status:
TERMINATED
Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery
Lead Sponsor:
IWK Health Centre
Conditions:
Spinal Induced Hypotension in Cesarean Delivery
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down meth...
Eligibility Criteria
Inclusion
- Non-emergent cesarean delivery with planned spinal 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)
- American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
- Age ≥ 18 years (Standard within the obstetrical literature)
- Term gestational age
- English-speaking
Exclusion
- 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 intra-arterial catheter due to limitations in size)
- Height \< 5'0" (Women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
- Laboring women
- Urgent or emergency cesarean delivery
- Hypertensive disease of pregnancy
- Severe maternal cardiac disease
- Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
- Fetal anomalies or intrauterine fetal death
- Failed spinal anesthesia
- Subject enrollment in another study involving a study medication within 30 days of CD
- Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00796328
Start Date
November 1 2008
End Date
July 1 2009
Last Update
April 23 2018
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