Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery
This study has been completed.
Sponsor:
IWK Health Centre
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00796328
First received: November 19, 2008
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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 methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. For example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60 mcg/min.
The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Induced Hypotension in Cesarean Delivery |
Drug: Phenylephrine infusion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Up-down Determination of the ED90 of the Initial Rate of Infusion of Phenylephrine for the Prophylaxis of Spinal Induced Hypotension in Parturients Undergoing Cesarean Delivery |
Resource links provided by NLM:
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
U.S. FDA Resources
Further study details as provided by IWK Health Centre:
Primary Outcome Measures:
- Effective dose of phenylephrine at which 90% of subjects have no spinal induced hypotension [ Time Frame: Spinal administration until delivery ] [ Designated as safety issue: No ]The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min.
| Enrollment: | 45 |
| Study Start Date: | November 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Phenylephrine infusion
Up-down, biased coin design
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre |
| ClinicalTrials.gov Identifier: | NCT00796328 History of Changes |
| Other Study ID Numbers: | IWK-4462-2008 |
| Study First Received: | November 19, 2008 |
| Last Updated: | April 9, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases Phenylephrine Oxymetazoline Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Mydriatics Autonomic Agents Peripheral Nervous System Agents Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013