- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481740
Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)
March 22, 2018 updated by: Ronald George, IWK Health Centre
A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35).
This subgroup of patients represents a large portion of the obstetric patient population locally and nationally.
It is unclear whether previous research should be extrapolated to the obese patient population.
This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension.
This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 6K8
- IWK Health Centre
-
-
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- English speaking
- ASA Physical Status I-II
- Non-laboring women
- Single gestations ≥ 36 weeks
- Obese women (Body Mass Index 35 - 55 kg/m2)
- Non-emergent CD under spinal anesthesia
Exclusion Criteria:
- Height < 5'0"
- Antiemetic drug use in the 24 hours prior to CD
- Allergy to phenylephrine, or any other standardized medication
- Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)
- Chronic hypertension receiving antihypertensive treatment
- Severe Cardiac disease in pregnancy with marked functional limitations
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phenylephrine bolus
|
10 ml of 100mcg/ml phenylephrine and placebo infusion
|
Experimental: Phenylephrine infusion
|
60ml infusion of 100mcg/ml phenylephrine and placebo bolus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Nausea and Vomiting
Time Frame: intraoperative 2-3 hours
|
intraoperative 2-3 hours
|
Incidence of Nausea and Vomiting
Time Frame: 2 hrs postoperative
|
2 hrs postoperative
|
Incidence of Nausea and Vomiting
Time Frame: 24hrs postoperative
|
24hrs postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Hypotension
Time Frame: intraoperative - predelivery
|
intraoperative - predelivery
|
Incidence of Hypotension
Time Frame: intraoperative - postdelivery
|
intraoperative - postdelivery
|
Neonatal Acidosis
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
July 22, 2011
First Submitted That Met QC Criteria
November 25, 2011
First Posted (Estimate)
November 30, 2011
Study Record Updates
Last Update Posted (Actual)
April 23, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 4999-01460
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypotension
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Edwards LifesciencesCompletedHypotension | Intraoperative Hypotension | Postoperative HypotensionNetherlands
-
James J. Peters Veterans Affairs Medical CenterCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingHypotension Drug-Induced | Hypotension During Surgery
-
Universitätsklinikum Hamburg-EppendorfCompletedBlood Pressure | Postinduction Hypotension | Perioperative HypotensionGermany
-
University of ParmaUnknownHypotension During Dialysis | Dialysis HypotensionItaly
-
Peking Union Medical College HospitalRecruitingPost-induction Hypotension | Postprandial HypotensionChina
-
Mazovia Regional Hospital in SiedlceRecruitingAnesthesia | Hypotension on Induction | Perioperative Injury | Perioperative HypotensionPoland
-
Acibadem UniversityCompletedHypotension | Intraoperative Hypotension | Post-induction Hypotension | Post Anesthesia RecoveryTurkey
-
Seoul National University HospitalCompletedOrthostatic; Hypotension, NeurogenicKorea, Republic of
-
H. Lundbeck A/SCompletedSymptomatic Neurogenic Orthostatic HypotensionUnited States
Clinical Trials on Phenylephrine bolus
-
AC Camargo Cancer CenterCompletedBreast Cancer | RadiodermatitisBrazil
-
Rob RutledgeNova Scotia Health AuthorityCompletedBreast CancerCanada
-
Tulane UniversityWithdrawnRadiotherapyUnited States
-
Providence University, TaiwanUnknown
-
Rabin Medical CenterCompleted
-
KIST Medical and Teaching HospitalRecruiting
-
University Hospital, Basel, SwitzerlandCompletedMaternal Haemodynamic StabilitySwitzerland
-
University of BathSociété des Produits Nestlé (SPN)CompletedCircadian Rhythms | Feeding PatternsUnited Kingdom
-
Tartu University HospitalEstonian Research CouncilUnknown
-
University Hospital, ToulouseCompleted