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Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

This study is currently recruiting participants.
Verified March 2013 by IWK Health Centre
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01481740
First received: July 22, 2011
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypotension
 Drug: Phenylephrine bolus
Drug: phenylephrine infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • incidence of nausea and vomiting [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: 2 hrs postoperative ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: 24hrs postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of hypotension [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • neonatal acidosis [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine bolus Drug: Phenylephrine bolus
10 ml of 100mcg/ml phenylephrine and placebo infusion
Experimental: Phenylephrine infusion Drug: phenylephrine infusion
60ml infusion of 100mcg/ml phenylephrine and placebo bolus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481740

Locations
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 6K8
Contact: Ronald B George, MD FRCPC     902-470-6627     rbgeorge@dal.ca    
Sub-Investigator: Dolores McKeen, MD FRCPC            
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre
  More Information

No publications provided

Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01481740     History of Changes
Other Study ID Numbers: 4999-01460
Study First Received: July 22, 2011
Last Updated: March 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by IWK Health Centre:
spinal induced hypotension
nausea and vomiting
cesarean delivery

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 June 17, 2013