Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery
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ClinicalTrials.gov Identifier: NCT00796328 |
Recruitment Status
:
Terminated
(Results Invalid, study closed, analysis cannot proceed.)
First Posted
: November 24, 2008
Results First Posted
: April 21, 2014
Last Update Posted
: April 23, 2018
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Tracking Information | |||
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First Submitted Date ICMJE | November 19, 2008 | ||
First Posted Date ICMJE | November 24, 2008 | ||
Results First Submitted Date | March 14, 2014 | ||
Results First Posted Date | April 21, 2014 | ||
Last Update Posted Date | April 23, 2018 | ||
Study Start Date ICMJE | November 2008 | ||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension [ Time Frame: Spinal administration until delivery ] 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.
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Original Primary Outcome Measures ICMJE |
The ED90 of phenylephrine infused intravenously from the time the spinal is administered until delivery to prevent the subjects systolic blood pressure from decreasing by 20% or below an absolute value (90 mmHg) [ Time Frame: Spinal administration until delivery ] | ||
Change History | Complete list of historical versions of study NCT00796328 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery | ||
Official Title ICMJE | 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 | ||
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 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. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 4 | ||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Spinal Induced Hypotension in Cesarean Delivery | ||
Intervention ICMJE | Drug: Phenylephrine infusion
Up-down, biased coin design |
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Study Arms | Experimental: 1
Intervention: Drug: Phenylephrine infusion |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
45 | ||
Original Estimated Enrollment ICMJE |
40 | ||
Actual Study Completion Date | July 2009 | ||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00796328 | ||
Other Study ID Numbers ICMJE | IWK-4462-2008 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Ronald George, IWK Health Centre | ||
Study Sponsor ICMJE | IWK Health Centre | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | IWK Health Centre | ||
Verification Date | March 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |