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Phenylephrine for Spinal Induced Hypotension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00781157
First received: October 27, 2008
Last updated: May 22, 2013
Last verified: May 2013

October 27, 2008
May 22, 2013
January 2008
August 2008   (final data collection date for primary outcome measure)
The primary outcome measure is the ED90 for bolus phenylephrine. [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781157 on ClinicalTrials.gov Archive Site
Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine. [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phenylephrine for Spinal Induced Hypotension
Up-down Determination of the ED90 of Phenylephrine for Spinal Induced Hypotension in Parturients Undergoing Cesarean Delivery

This study is designed to determine the ED90 for a single dose of phenylephrine for the treatment of spinal induced hypotension in parturients presenting for an elective CD. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to phenylephrine. The primary outcome measure is the ED90 for bolus phenylephrine. Secondary outcomes include the need for additional vasopressors, glycopyrolate to treat bradycardia, and the presence of hypertension following administration of phenylephrine.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypotension
Drug: Phenylephrine bolus
The initial dose of phenylephrine will be 100 mcg, a dose within the clinical range currently in use at our center. The subsequent dose is based upon the response of the preceding subject in the usual up-and-down method (UDM), which is outlined in the "data analysis" section of the protocol. The dosing changes will be in increments of 20 micrograms. A successful response to this dose will be entered into a spreadsheet, designed by our statistician, which will determine the subsequent dose based upon the UDM. If a failure is observed in the previous subject, the dose is stepped up in the next subject. If a success is observed the next subject is randomized with probability of 0.10 to the next lower dose and with probability 0.90 to the same dose.
Experimental: 1
Intervention: Drug: Phenylephrine bolus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
October 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Non-emergent cesarean delivery with planned regional 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)
  2. American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
  3. Age ≥ 18 years (Standard within the obstetrical literature)
  4. Term gestational age
  5. English-speaking

Exclusion Criteria:

  1. 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 intraarterial catheter due to limitations in size)
  2. Height < 5'0" (Women < 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
  3. Laboring women
  4. Urgent or emergency cesarean delivery
  5. Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) > 160mmHg, diastolic blood pressure (DBP) > 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
  6. Severe maternal cardiac disease
  7. Diabetes type I
  8. Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
  9. Fetal anomalies
  10. Failed spinal anesthesia
  11. Subject enrollment in another study involving a study medication within 30 days of CD
  12. Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00781157
IWK-4061-2007, IWK REB 4061
Yes
Ronald George, IWK Health Centre
IWK Health Centre
Not Provided
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre
IWK Health Centre
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP